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Research Article | Volume 15 Issue 1 (Jan - Feb, 2025) | Pages 156 - 172
Comparison Of Hyperbaric 0.5% Levobupivacaine with Hyperbaric 0.75% Ropivacaine for Block Characteristics in Lower Limb Orthopaedic Surgeries Under Subarachnoid Block.
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 ,
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1
Senior Resident, Department of Oncoanaesthesia and Palliative Care, BRAIRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India
2
Professor, Department of Anaesthesiology, ESI Model Hospital and Medical College, Basaidarapur, New Delhi. India
3
Professor, Department of Critical Care Medicine, Atal Bihari Vajpayee Institute of Medical Sciences & Dr Ram Manohar Lohia Hospital (ABVIMS & Dr RMLH), New Delhi, India
4
Professor and Head, Department of Anaesthesiology, All India Institute of Medical Sciences (AIIMS), Gorakhpur, Uttar Pradesh. India
Under a Creative Commons license
Open Access
Received
Nov. 20, 2024
Revised
Dec. 3, 2024
Accepted
Dec. 24, 2024
Published
Jan. 15, 2025
Abstract

Background and Aims: Literature is sparse comparing the intrathecal use of hyperbaric ropivacaine and levobupivacaine for lower limb procedures. To take advantage of stereoselectivity, ropivacaine and levo-(S)-bupivacaine were developed. Both are less cardiotoxic than bupivacaine. This study was undertaken with the aim of comparing the block characteristics following intra-thecal administration of hyperbaric levobupivacaine (0.5%) with hyperbaric ropivacaine (0.75%) for lower limb orthopedic surgeries under sub-arachnoid block. Material and Methods: This randomised, comparative study was undertaken in a tertiary care, teaching hospital after taking necessary approvals (IRB and IEC), in consenting adult patients fulfilling the inclusion and exclusion criteria, posted for elective lower limb orthopaedic surgeries under subarachnoid block. After standard sample size calculation, a total of 80 patients were enrolled and randomised into two groups (40 patients in each group). Group L received 3 ml of preservative-free, 0.5 percent hyperbaric Levobupivacaine with 20 microgram fentanyl; and Group R received 3 ml of 0.75% hyperbaric Ropivacaine (preservative free) with 20 mcg fentanyl, intra-thecally. The vital parameters, onset of motor and sensory blockade as well as duration of motor and sensory blockade were noted at regular intervals, tabulated and subjected to statistical analysis. Results: As regards to demographic variables, both the groups were comparable. In terms of onset of motor block (minutes), there was a significant difference between the two groups (p = 0.001), with onset of motor block (minutes) being higher for Levobupivacaine. Ropivacaine had a faster onset of motor block as compared to levobupivacaine. Between the two groups, there was a substantial variation in the number of hours that the motor block lasted (p = 0.001), with the duration of motor block (hours) being longer in the levobupivacaine group. Levobupivacaine produced longer lasting motor block than ropivacaine. In terms of onset of sensory block (minutes), there was a significant difference between the 2 groups (t = -8.746, p = 0.001). Ropivacaine had a faster onset of sensory block as compared with levobupivacaine. The duration of sensory block (hours) varied significantly across the 2 groups (p = 0.001), with the Group L (levobupivacainegroup) having longer duration of sensory block (hours). Ropivacaine had a lesser duration of sensory blockade as compared with levobupivacaine. Participants in the group Group L (levobupivacaine group) had a higher proportion of MAP fall >10% from baseline as compared to Group R (Ropivacaine). Conclusions: In demographically similar group of patients, intra-thecal ropivacaine showed earlier onset of both sensory and motor block than levobupivacaine. Duration of both sensory and motor blocks was longer with levobupivacaine than ropivacaine. Hemodynamic parameters (HR, SBP, DBP, ECG, SpO2) remained similar and stable with both the drugs, although the systolic BP fall was more with levobupivacaine than ropivacaine. Level of block achieved with both the drugs in the used doses were similar in our study.

Keywords
INTRODUCTION

Subarachnoid block is advocated in lower limb orthopaedic surgeriesas it is a safe, affordable, simple-to-use technique that provides rapid and reliable anaesthesia with fewer systemic and metabolic disturbances than general anaesthesia 1. It is easier to perform, the patient is awake with spontaneous breathing, there is no need for airway manipulation, there is a minimal risk of pulmonary aspiration of gastric contents, there is a rapid onset of action, good motor and sensory blockade, and early ambulation to allow for early discharge2.

 

Ropivacaine is safe and effective for peripheral nerve blocks like the brachial plexus block as well as regional anesthetic procedures like epidurals, according to extensive clinical data3,4. Literature is sparse regarding the intrathecal use of hyperbaric ropivacaine.Levobupivacaine is a relatively newer drug introduced in India, that is a pure levo-isomer of bupivacaine 5. Its literature regarding intrathecal use is limited. This study aimed to compare the block characteristics of hyperbaric 0.5% levobupivacaine with hyperbaric 0.75% ropivacaine in adult patients undergoing lower limb orthopaedic surgeries under subarachnoid block.Literature is sparse comparing the use of intrathecal hyperbaric ropivacaine with hyperbaric levo-bupivacaine, especially for lower limb orthopaedic surgeries6.

MATERIALS AND METHODS

This study was conducted in the department of anaesthesiology at a tertiary care teaching hospital with good volume of lower limb orthopaedic work, after taking approval from the Institutional Ethics Committee and Institutional Review Board, as well as CTRI registration.A written informed bilingual consent from all patients were taken. Healthy, consenting, adult patients,aged18-80 years, of either gender, of ASA grade I or II, who were undergoing lower limb orthopaedic surgeries under spinal anaesthesiawere included in the study.

 

Patients with vertebral deformity, history of trauma to spine, skin infection at the site of lumbar puncture, increased Intra- Cranial Pressure (ICP), allergy to amide local anaesthetics or coagulopathywere excluded from the study.

 

The sample size was determined by using the duration of motor block to compare the effectiveness between the two groups. A sample size of 35 patients per group was necessary, to determine statistical significances with an effect size of 0.67 at alpha 0.05 and power of 80%, assuming a mean difference of 0.5 hr in motor block duration between the two groups as clinically meaningful7. A sample size of 80 was taken with 40 patients in each group, to account for any dropoutsor loss to follow up. For the randomization, computer-generated random numbers were employed. Eighty patients were allocated into two groups at random: Group L received 3 ml of preservative-free, 0.5 percent hyperbaric Levobupivacaine with 20 microgram fentanyl;andGroup R received 3 ml of 0.75% hyperbaric Ropivacaine (preservative free) with 20 mcg Fentanyl. Standard ASA monitoring in the operating room was performed with a pulse oximeter, non-invasive automated blood pressure monitoring, ECG, with noting down of baseline values. Under strict asepsis, subarachnoid space was identified by free flow of cerebro-spinal fluid (CSF), followed by injection of 0.2 millilitres of study drug per second. The patient was then placed in supine position till maximum effect of the drug(Bromage score of 1 was achieved, or, 10 minutes had elapsed, whichever is earlier) was achieved.The vital parameters, onset of motor and sensory blockade as well as duration of motor and sensory blockade was checked and noted at regular intervals. The SPSS application for Windows, version 17.0, was used to do statistical analysis (SPSS, Chicago, Illinois). Continuous variables were shown as mean SD, while categorical variables were given as absolute numbers and percentages. The data was analysed to ensure normality before statistical analysis. The unpaired t test was used to compare continuous variables with normally distributed distributions, while the Mann-Whitney U test was applied to variables with non-normal distributions. For categorical data, the Fisher's exact test or the chi square test was utilised for analysis. The cutoff for statistical significance was P = 0.05.

RESULTS

Following are the demographic details on the age distribution of the patients in each group.

 

Table 1: Association Between Groups and Age (n = 80)

Age in years

Groups

Chi-Square Test

R

L

Total

χ2

P Value

18-30 Years

12 (30.0%)

7 (17.5%)

19 (23.8%)

3.126

0.681

31-40 Years

7 (17.5%)

7 (17.5%)

14 (17.5%)

41-50 Years

7 (17.5%)

6 (15.0%)

13 (16.2%)

51-60 Years

7 (17.5%)

8 (20.0%)

15 (18.8%)

61-70 Years

5 (12.5%)

10 (25.0%)

15 (18.8%)

71-80 Years

2 (5.0%)

2 (5.0%)

4 (5.0%)

Total

40 (100.0%)

40 (100.0%)

80 (100.0%)

 

Figure 1: Association Between Groups and Age (n = 80)

Chi-square test was used to explore the association between 'Group' and 'Age'. Regarding the distribution of Age, there was no discernible variation between the various groups (2 = 3.126, p = 0.681).

 

Regarding age distribution, both groups were comparable.

The age range of 18 to 30 years comprised the majority of patients (23.8%), followed by 51 to 60 and 61 to 70 years (18.8 percent each).

 

Table 2: Comparison of Weight (Kg) between groups (n = 80)

Weight (Kg)

Groups

t-test

R

L

t

p value

Mean (SD)

63.27 (6.47)

62.90 (6.88)

0.251

0.802

Median (IQR)

64 (58-67.25)

63 (58.75-68)

Range

50 - 78

46 - 77

 

Figure 2: Comparison of Weight (Kg) (n = 80) between groups

The mean (SD) of Weight (Kg) in the Group: R group was 63.27 (6.47).

The mean (SD) of Weight (Kg) in the Group: L group was 62.90 (6.88).

Strength of Association = 0.03 (Little/No Association)

Weight (Kg) did not significantly differ across the groups (t = 0.251, p = 0.802).

Both the groups were comparable with regard to weight distribution.

 

Table 3: Comparison of Onset of Motor Block (Minutes) (n = 80)

Onset of Motor Block (Minutes)

.                                              Groups

Wilcoxon-Mann-Whitney U Test

R

L

W

p value

Mean (SD)

3.02 (0.77)

4.50 (0.99)

204.000

<0.001

Median (IQR)

3 (2.75-3.25)

4 (4-5)

Range

2 - 5

3 - 7

 

Figure 3 A: Comparison of Onset of Motor Block (Minutes) (n = 80) between groups

The density plot below depicts the distribution of Onset of Motor Block (Minutes) in the two groups.

 

Figure 3B: Comparisonof Onset of Motor Block (Minutes) (n = 80) between groups

The mean (SD) of Onset of Motor Block in the GroupR was 3.02 (0.77) (Minutes).

The mean (SD) of Onset of Motor Block in the GroupL was 4.50 (0.99) (Minutes).

The Onset of Motor Block in the Group R ranged between 2 – 5 (Minutes).

The Onset of Motor Block (Minutes) in the Group L ranged between 3 – 7 (Minutes).

Strength of Association = 0.65 (Large Effect Size)

In terms of onset of motor block (minutes), there was a significant difference between the two groups (p = 0.001), with onset time of motor block (minutes) being higher for Levobupivacaine. Ropivacaine had a faster onset of motor block as compared to levobupivacaine.

 

Table 4: Comparison of the Duration of Motor Block (Hours) (n = 80) between groups

Duration of Motor Block (Hours)

Group

Wilcoxon-Mann-Whitney U Test

R

L

W

p value

Mean (SD)

2.51 (0.45)

2.99 (0.50)

383.000

<0.001

Median (IQR)

2.5 (2-3)

3 (2.5-3.5)

Range

1.5 - 3.5

1.5 - 4

 

The bar graph below depicts the mean of Duration of Motor Block (in hours) in the 2 different groups.

 

Figure 4A: Comparison of Duration of Motor Block (Hours) (n = 80) between groups

The density plot below depicts the distribution of the duration of Motor Block (in hours) in the 2 different groups.

 

Figure 4B: Comparison of Duration of Motor Block (Hours) (n = 80) between groups

The mean (SD) of duration of motor block in the GroupR was 2.51 (0.45) (Hours).

The mean (SD) of duration of motor block in the GroupL was 2.99 (0.50) (Hours).

The duration of motor block in the GroupR ranged from 1.5 - 3.5 (Hours).

The duration of motor block in the Group L ranged from 1.5 – 4 (Hours).

Strength of Association = 0.45 (Large Effect Size)

Between the two groups, there was a substantial variation in the number of hours that the motor block lasted (p = 0.001), with the duration of motor block (hours) being longer in the levobupivacaine group. Levobupivacaineproduced longer lasting motor block than ropivacaine.

Table 5: Comparison of Onset of Sensory Block between groups (Minutes) (n = 80)

Onset of Sensory Block (Minutes)

Groups

t-test

R

L

t

p value

Mean (SD)

3.26 (0.67)

4.84 (0.92)

-8.746

<0.001

Median (IQR)

3.33 (2.81-3.66)

4.66 (4.33-5.5)

Range

2.08 - 5.16

3 - 6.58

 

The bar graph below depicts the mean time of onset of sensory block (in minutes) in the 2groups.

 

Figure 5A: Comparison of the Onset of Sensory Block between groups (in Minutes) (n = 80)

The density plot below depicts the distribution of onset of sensory block (in minutes) in the 2 groups.

 

Figure 5B: Comparison of Onset of Sensory Block between groups (Minutes) (n = 80)

The mean (SD) of onset of sensory block in the GroupR was 3.26 (0.67) (Minutes).

The mean (SD) of onset of sensory Block in the Group L was 4.84 (0.92) (Minutes).

The onset of sensory block in the Group R ranged from 2.08 - 5.16 (Minutes).

 The onset of sensory block in the GroupL ranged from 3 - 6.58 (Minutes).

Strength of Association = 0.7 (Large Effect Size).

In terms of onset of sensory block (minutes), there was a significant difference between the 2 groups (t = -8.746, p = 0.001). Ropivacaine had a faster onset of sensory block as compared to levobupivacaine.

 

Table 6: Comparison of the Duration of Sensory Block (Hours) (n = 80) between groups

Duration of Sensory Block (Hours)

Group

Wilcoxon-Mann-Whitney U Test

R

L

W

p value

Mean (SD)

2.99 (0.26)

3.21 (0.26)

388.500

<0.001

Median (IQR)

3 (2.75-3.16)

3.25 (3.14-3.33)

Range

2.5 - 3.75

2.5 - 3.66

 

The bar graph below depicts the mean of the duration of sensory block (hours) in the 2 groups.

 

Figure 6A: Comparison of the Duration of Sensory Block (Hours) between groups (n = 80)

The density plot below depicts the distribution of duration of sensory block (in hours) between the 2 different groups.

 

Figure 6B: Comparison of the Duration of Sensory Block between groups (in Hours) (n = 80)

The mean (SD) of duration of sensory block (hours) in the GroupR was 2.99 (0.26).

The mean (SD) of duration of sensory block (hours) in the GroupLwas 3.21 (0.26).

The duration of sensory block (hours) in the GroupR ranged from 2.5 - 3.75.

 The duration of sensory block (hours) in the GroupL ranged from 2.5 - 3.66.

Association Strength = 0.4 (Large Effect Size)

The duration of sensory block (hours) varied significantly across the 2 groups (p = 0.001), with the Group L(levobupivacainegroup) having the longest duration of sensory block (hours). Ropivacaine had a lesser duration of sensory blockade as compared to levobupivacaine.

 

Table 7: Table showing comparison of the level of spinal block achieved between the groups (n = 80)

Level Achieved

Groups

Fisher's Exact Test

R

L

Total

χ2

P Value

T4

3 (7.5%)

1 (2.5%)

4 (5.0%)

4.018

0.185

T6

31 (77.5%)

26 (65.0%)

57 (71.2%)

T8

6 (15.0%)

13 (32.5%)

19 (23.8%)

Total

40 (100.0%)

40 (100.0%)

80 (100.0%)

 

Level Achieved

Adjusted P Values

T4 vs. T6

0.623

T4 vs. T8

0.390

T6 vs. T8

0.341

 

Figure 7: Bar Diagram showing association between groups and level of spinal block achieved (n = 80)

Regarding the distribution of level of spinal block achieved, there was minor variation between the two groups (χ2 = 4.018, p = 0.185).

7.5% of the participants in the group [Group: R] had [Level Achieved: T4].

 77.5% of the participants in the group [Group: R] had [Level Achieved: T6].

15.0% of the participants in the group [Group: R] had [Level Achieved: T8].

2.5% of the participants in the group [Group: L] had [Level Achieved: T4].

65.0% of the participants in the group [Group: L] had [Level Achieved: T6].

32.5% of the participants in the group [Group: L] had [Level Achieved: T8].

 

Table 8: Association between groups and fall in Mean Arterial Pressure (MAP)>10% from Baseline (n = 80)

MAP Fall >10% From Baseline

Groups

Fisher's Exact Test

R

L

Total

χ2

P Value

Yes

32 (80.0%)

39 (97.5%)

71 (88.8%)

6.135

0.029

No

8 (20.0%)

1 (2.5%)

9 (11.2%)

Total

40 (100.0%)

40 (100.0%)

80 (100.0%)

 

Figure 8: Association Between Groups and MAP Fall >10% From Baseline (n = 80)

There was a significant difference between the two groups in terms of distribution of MAP (Mean Arterial Pressure) Fall >10% From Baseline (χ2 = 6.135, p = 0.029).

80.0% of the participants in the Group R had a MAP Fall >10% from baseline.

97.5% of the participants in the Group L had a MAP Fall >10% From baseline.

Participants in the group Group L (levobupivacainegroup) had ahigher proportion of MAP fall >10% from baseline as compared to Group R (Ropivacaine).

 

Table 9: Comparison of the two groups for change in MAP (mmHg) over time (n = 80)

MAP (mmHg)

Group

P value for comparison of the two groups at each of the timepoints (Wilcoxon-Mann-Whitney Test)

R

L

Mean (SD)

Mean (SD)

Baseline

96.41 (6.00)

100.16 (5.68)

0.006

5 Minutes

85.92 (5.99)

86.25 (5.48)

0.874

10 Minutes

85.97 (5.79)

86.07 (4.89)

0.862

15 Minutes

88.00 (5.04)

88.32 (4.43)

0.870

30 Minutes

89.62 (5.17)

90.93 (5.11)

0.219

45 Minutes

90.63 (4.59)

91.43 (4.68)

0.386

60 Minutes

91.10 (4.97)

92.23 (3.84)

0.370

P Value for change in MAP (mmHg) over time within each group (Friedman Test)

<0.001

<0.001

 

Overall P Value (Generalized Estimating Equations) for the comparison of the change in MAP (mmHg) over time between the two groups 

<0.001

 

The MAP (mmHg) at baseline varied considerably between the two groups. At other points of measurement throughout the procedure, difference was insignificant. (p => 0.05)

 

The Generalized Estimating Equations approach was used to compare the total change in MAP (mmHg) over time in the two groups. Between the two groups, there was a significant difference in the trend of MAP (mmHg) over time (p = 0.001).

The following line graph shows the trend of change in MAP (mmHg) over time in the two groups. Figure 9 compares the changes in the mean arterial pressure (mmHg) between the two groups over time (n = 80).

 

Figure 9: Comparison of MAP (mmHg) variation between the two groups over time

Table 10Heart Rate Changes (BPM) over time between the groups (n = 80).

Heart Rate (BPM)

Groups

P value for comparison of the two groups at each of the timepoints (Wilcoxon-Mann-Whitney Test)

R

L

Mean (SD)

Mean (SD)

Baseline

80.53 (12.27)

85.10 (14.10)

0.150

5 Minutes

72.92 (10.17)

76.72 (13.25)

0.210

10 Minutes

74.00 (9.59)

75.62 (11.10)

0.509

15 Minutes

73.70 (8.46)

76.17 (9.46)

0.262

30 Minutes

73.97 (8.06)

76.35 (9.17)

0.232

45 Minutes

74.55 (8.16)

76.08 (9.37)

0.522

60 Minutes

75.00 (7.23)

76.20 (8.49)

0.531

Friedman Test: P Value for Change in Heart Rate (BPM) Over Time Within Each Group:

<0.001

<0.001

 

P Value overall for comparing how the two groups' heart rates (BPM) changed over time (Generalised Estimating Equations)

0.062

 

At any of the timepoints, there was no difference in heart rate (BPM) between the two groups. There was no discernible change in the trend of heart rate (BPM) over time between the two groups(p = 0.062).

 

Figure 10: Comparison of the two Groups for change in Heart Rate (BPM) over time (n = 80)

Table 11: Comparison of the changes in systolic blood pressure over time (mmHg) between two groups (n = 80)

Systolic BP (mmHg)

Groups

P value for comparison of the two groups at each of the timepoints (Wilcoxon-Mann-Whitney Test)

R

L

Mean (SD)

Mean (SD)

Baseline

128.18 (8.79)

132.02 (8.15)

0.047

5 Minutes

113.20 (8.39)

110.85 (8.26)

0.272

10 Minutes

113.05 (6.59)

109.75 (7.18)

0.039

15 Minutes

115.00 (7.13)

112.75 (7.38)

0.152

30 Minutes

116.85 (6.37)

116.60 (6.95)

0.809

45 Minutes

117.90 (6.04)

117.20 (5.94)

0.480

60 Minutes

118.80 (6.16)

118.50 (4.68)

0.697

P value for time-dependent changes in systolic blood pressure (mmHg) for each group (Friedman Test)

<0.001

<0.001

 

P value overall for comparing the two groups' changing systolic blood pressure (mmHg) over time (Generalized Estimating Equations)

<0.001

 

The two groups differed significantly in terms of Systolic BP (mmHg) at the following timepoints: Baseline and at10 Minutes. At other points of measurement throughout the procedure, the difference was insignificant. (p => 0.05)

 

The Generalized Estimating Equations approach was used to compare the total change in Systolic BP (mmHg) across time in the two groups. Between the two groups, there was a statistically significant difference in the trend of systolic blood pressure (mmHg) over time (p 0.001).

 

The fall in mean (SD) systolic BP from baseline was significantly more in the levobupivacaine group than the ropivacaine group.

 

Figure 11A: Bar diagram to demonstrate changes in Systolic BP (mmHg) over time

The following line graph shows the trend of change in systolic blood pressure over time.

 

Figure 11B: Comparison of the changes in systolic blood pressure over time (n = 80)

Table 12: Comparison of changes in Mean Diastolic BP (mmHg) over time(n = 80)

Diastolic BP (mmHg)

Groups

P value for comparison of the two groups at each of the timepoints (Wilcoxon-Mann-Whitney Test)

R

L

Mean (SD)

Mean (SD)

Baseline

80.53 (6.18)

84.22 (5.66)

0.007

5 Minutes

72.28 (5.90)

73.95 (5.23)

0.167

10 Minutes

72.42 (6.32)

74.22 (5.22)

0.173

15 Minutes

74.50 (5.37)

76.10 (4.62)

0.181

30 Minutes

76.00 (5.82)

78.10 (5.42)

0.071

45 Minutes

77.00 (5.16)

78.55 (5.06)

0.128

60 Minutes

77.25 (5.50)

79.10 (4.62)

0.091

P value for time-dependent changes in diastolic blood pressure (mmHg) for each group (Friedman Test)

<0.001

<0.001

 

P value overall for comparing the two groups' changing systolic blood pressure (mmHg) over time (Generalized Estimating Equations)

0.105

 

The two groups differed significantly in terms of Diastolic BP (mmHg) at Baseline. At other points of measurement throughout the procedure, the difference was insignificant(p => 0.05).

 

Using the Generalized Estimating Equations approach, the total change in diastolic blood pressure (mmHg) over time was compared between the two groups. Between the two groups, there was no discernible change in the trend of diastolic blood pressure (mmHg) over time (p = 0.105). The change in diastolic blood pressure (mmHg) over time in the two groups is shown in the line diagram below.

 

Figure 12: Diastolic BP (mmHg) variation between the two groups over time (n = 80)

Table 13: Comparison of thedifferences in change in SpO2 over time between groups (n = 80)

SpO2 (%)

Groups

P value for each timepoint's comparison of the two groups (Wilcoxon-Mann-Whitney Test)

R

L

Mean (SD)

Mean (SD)

Baseline

99.15 (0.86)

99.15 (0.86)

0.988

5 Minutes

100.00 (0.00)

100.00 (0.00).    

-

10 Minutes

100.00 (0.00)

100.00 (0.00)

-

15 Minutes

100.00 (0.00)

100.00 (0.00)

-

30 Minutes

100.00 (0.00)

100.00 (0.00)

-

45 Minutes

100.00 (0.00)

100.00 (0.00)

-

60 Minutes

100.00 (0.00)

100.00 (0.00)

-

P value for time-dependent change in SpO2 (percent) within each group (Friedman Test)

<0.001

<0.001

 

P Value overall for comparing the two groups' changes in SpO2 (percent) over time (Generalized Estimating Equations)

-                                          -

 

The two groups did not differ in terms of SpO2 (%) at any of the timepoints.

 

The Generalized Estimating Equations approach was used to compare the total change in SpO2 (percent) over time in the two groups. Between the two groups, there was no discernible change in the trend of SpO2 (percent) over time (p = -). However, within the group, change in SpO2 over time was significant. (P =< 0.001)

 

The following figure is a line diagram that depicts the change in SpO2 (%) over time in the two groups. There were hardly any changes in SpO2 over time between the two groups and were not statistically significant.

 

Figure 13: Comparison of the differences in the percentage of time that SpO2 changed in two groups (n = 80)

Table 14: Comparison of the two Groups for change in MBS (Modified Bromage Score) over time (n = 80)

 

MBS

Group

P value for comparison of the two groups at each of the timepoints (Wilcoxon-Mann-Whitney Test)

R

L

Mean (SD)

Mean (SD)

1 Minute Intraoperative

0.03 (0.16)

0.00 (0.00)

0.330

2 Minutes Intraoperative

0.72 (0.85)

0.00 (0.00)

<0.001

3 Minutes Intraoperative

2.08 (0.89)

0.45 (0.71)

<0.001

4 Minutes Intraoperative

2.75 (0.59)

1.40 (1.10)

<0.001

5 Minutes Intraoperative

2.98 (0.16)

2.40 (0.90)

<0.001

6 Minutes Intraoperative

3.00 (0.00)

2.78 (0.58)

0.006

7 Minutes Intraoperative

3.00 (0.00)

3.00 (0.00)

-

8 Minutes Intraoperative

3.00 (0.00)

3.00 (0.00)

-

9 Minutes Intraoperative

3.00 (0.00)

3.00 (0.00)

-

10 Minutes Intraoperative

3.00 (0.00)

3.00 (0.00)

-

0 Minutes Post-Operative

3.00 (0.00)

3.00 (0.00)

-

30 Minutes Post-Operative

3.00 (0.00)

3.00 (0.00)

-

60 Minutes Post-Operative

3.00 (0.00)

3.00 (0.00)

-

1.5 Hours Post-Operative

2.95 (0.22)

3.00 (0.00)

0.160

2 Hours Post-Operative

2.50 (0.68)

2.83 (0.45)

0.012

2.5 Hours Post-Operative

1.73 (0.82)

2.58 (0.68)

<0.001

3 Hours Post-Operative

0.75 (0.78)

1.75 (0.71)

<0.001

3.5 Hours Post-Operative

0.20 (0.46)

0.92 (0.69)

<0.001

4 Hours Post-Operative

0.03 (0.16)

0.05 (0.22)

0.569

P Value for change in MBS over time within each group (Friedman Test)

<0.001

<0.001

 

 

The two groups differed significantly in terms of MBS at the following timepoints: 2 Minutes Intraoperative, 3 Minutes Intraoperative, 4 Minutes Intraoperative, 5 Minutes Intraoperative, 6 Minutes Intraoperative, 2 Hours Post-operative, 2.5 Hours Post-operative, 3 Hours Post-operative, 3.5 Hours Post-operative. There was no significant difference between the two groups during the time periods of 7 Minutes Intraoperative, 8 Minutes Intraoperative, 9 Minutes Intraoperative, 10 Minutes Intraoperative, 0.5 Hours Post-operative, 1 Hour Post-operative and 1.5 Hours Post-operative.

 

Using the Generalised Estimating Equations approach, the overall change in MBS over time was compared between the two groups. There was no discernible change in the MBS trend over time between the two groups(p = -). The line graph that follows shows how the MBS in the two groups changed over time.

 

Figure 14: Comparison of the two Groups for change in MBS over time  (n = 80)

DISCUSSION

Bupivacaine is a widely used local anaesthetic, but it is cardiotoxic. Single enantiomers are safer with regard to the issue of cardiovascular toxicity caused by accidental intravenous administration of bupivacaine8. To take advantage of stereoselectivity, ropivacaine and levo-(S)-bupivacaine were developed9, 10.The average length of the motor blockage in our study was 2.51 hours for the R(ropivacaine) group and 2.99 hours for the L (levobupivacaine) group. Therefore, the duration of motor block in ropivacaine group is lesser.According to our study, the average time taken for the onset of motor block was about 3.02 minutes in the ropivacaine group compared to 4.50 minutes in levobupivacaine group. Thus, the latter group experienced a delayed onset of motor block.Rapid onset of block inour study patients could be attributed to higher doses of local anesthetics used and the difference in baricityof drugs used 12, 13.The mean length of the sensory block is around 2.99 hours in the ropivacaine group and 3.21 hours in the levobupivacaine group. As a result, the sensory block duration lasts lesser in ropivacaine group.According to our study, the average time taken for the onset of motor block was about 3.26 minutes in case of ropivacaine group compared to 4.84 minutes in case of levobupivacaine group. Thus, the onset of motor block was delayed in levobupivacaine group.There was no significant difference in the trend of heart rate (BPM) over time between the two groups.Overall, there were no significant effects on haemodynamic parameters in our study, except on MAP and SBP.In our study, 80% of the participants in the ropivacaine group had a MAP fall >10% from baseline. In levobupivacainegroup, 97.5% of the participants had a MAP fall >10% from baseline. There was no case of hypotension (MAP < 65 mmHg) in either of the two groups. There was a significant difference in the trend of systolic blood pressure (mmHg) over time between the two groups. The two groups differed significantly in terms of systolic BP (mmHg) at the following timepoints: at baseline and at 10 minutes intra - operatively. At other points of measurement throughout the procedure, the difference was insignificant.The clinical safety profile of ropivacaine appears to be better than that of levobupivacaine14,15.

CONCLUSION

This study was undertaken to compare the subarachnoid block characteristics for lower limb orthopedic surgeries by comparing intra-thecal administration of 3ml of 0.75% hyperbaric ropivacaine with 20mcg Fentanyl and 3ml of 0.5% Levobupivacaine with 20mcg Fentanyl. Both the groups were demographically similar. Onset of both sensory and motor block were earlier in ropivacaine than levobupivacainegroup, which was statistically significant.Mean duration of both sensory and motor block were lesser in ropivacaine than levobupivacainegroup, which was statistically significant. Level of block achieved with both the drugs in the used doses were similar in our study.As regards the degree of motor block by Modified BromageScale (MBS), there was no discernible change in the MBS trend over time between the two groups.Participants in the levobupivacainegroup had agreater proportion of MAP fall >10% from baseline which was statistically insignificant.There was no discernible difference between the two groups in the trajectory of diastolic blood pressure (mmHg), SpO2 trends and heart rates over time. In view of the advantages of shorter duration of motor blockade like early ambulation and voiding, hyperbaric ropivacaine may score over levobupivacaine for lower limb surgeries. Larger, randomised, multi-centerstudies comparing intrathecal ropivacaine with levobupivacaineare needed to throw more light 16.

REFERENCES
  1. Balavenkatasubramanian, Senthilkumar, Vinoth Kumar. Current indications for spinal anesthesia-a narrative review. Best Practice & Research ClinicalAnaesthesiology. 2023;3 (2):89-99
  2. Paul G. Barash, Bruce F. Cullen, Robert K. Stoelting, Michael K. Cahalan, M. Christine Stock, Rafael Ortega, Sam R. Sharar, Natalie F. Holt. South Asian Edition of Clinical Anesthetic. 8th ed. Chapter 22, Local Anaesthetics; p.546-548
  3. Surekha C, Radha MK, Kumar MS. A comparative study of intrathecal isobaric (0.75%) ropivacaine with isobaric (0.5%) bupivacaine for elective lower abdominal/limb surgeries – a clinical study. International Journal of Research in Health Sciences 2014;2(4):1172-9
  4. Finucane BT, Sandler AN, McKenna J, et al. A double-blind comparison of ropivacaine 0.5%, 0.75%, 1.0% and bupivacaine 0.5%, injected epidurally, in patients undergoing abdominal hysterectomy. Canadian Journal of Anesthesia 1996;43(5 Pt 1):442-9.
  5. Burlacu CL, Buggy DJ. Update on local anesthetics: focus on levobupivacaine. TherClin Risk Manag. 2008;4(2):381-392
  6. Gautier P, De Kock M, HubertyL,Demir T, lzydorczic M, Vanderick B. Comparison of the effect of intrathecal ropivacaine, levobupivacaine and bupivacaine for caesarean section. Br J Anaesthesia 2003;91:684
  7. McNamee DA, McClelland AM, Scott S, Milligan KR, Westman L, Gustafsson U. Spinal anaesthesia: comparison of plain ropivacaine 5 mg ml-1 with bupivacaine 5 mg ml-1 for major orthopaedic surgery. Br J Anaesth. 2002 Nov;89(5)
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  1. Leone S, Di Cianni S, Casati A, Fanelli G. Pharmacology, Toxicology and clinical use of new long-acting local anesthetics, ropivacaine and levobupivacaine. Acta Biomed 2008; 79:92-105.
  2. Simpson D, Curran MP, Oldfield V, Keating GM. Ropivacaine: A review of its use in regional anesthesia and acute pain management. Drugs. 2005; 65:2 675-717.
  3. Bajwa SJ, Kaur J. Clinical profile of levobupivacaine in regional anesthesia: A systematic review. J Anaesthesia Clinical Pharmacology 2013;29:530-9.
  4. Casati A, Basiarello M. Enantiomeric local anesthetics: Can ropivacaine and levobupivacaine improve our practice. Current Drug Ther 2006; 1:85-9.
  5. Camorcia M, Capogna G, Columb MO. Minimal local analgesic doses of ropivacaine, levobupivacaine and bupivacaine for intrathecal labor analgesia. Anesthesiology 2005; 10:646-50.
  6. Kim KM, Kim YW, Choi JW, Lee AR, Choi DH. The comparison of clinically relevant doses of intrathecal ropivacaine and levobupivacaine with fentanyl for labor analgesia. Korean J Anesthesiology 2013 Dec;65(6):525-30
  7. Camorcia M, Capogna G, Berritta C, Columb MO. The relative potencies for motor block after intrathecal ropivacaine, levobupivacaine, and bupivacaine. AnesthAnalg. 2007 Apr;104(4):904-7
  8. Kulkarni KR, Deshpande S, Namazi I, Singh SK, Kondilya K. A comparative evaluation of hyperbaric ropivacaine versus hyperbaric bupivacaine for elective surgery under spinal anaesthesia. J Anaesthesiology Clinical Pharmacology. 2014;30(2):238-242.
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