Background: This study aimed to evaluate the effectiveness of a low dose of hyperbaric ropivacaine administered with and without fentanyl via intrathecal injection in elderly patients undergoing mesh hernioplasty. Method: Eighty patients were randomly assigned to two groups of 40. Group RP received 2ml of 15mg hyperbaric Ropivacaine (0.75%) combined with 0.2ml normal saline (total volume of 2.2ml), while Group RF received 2ml of 15mg hyperbaric Ropivacaine (0.75%) with 10ug of fentanyl (also total 2.2ml), both administered intrathecally. The onset, duration, quality of sensory-motor block, and any side effects were recorded for both groups. Results: The onset of sensory-motor block was significantly early in the RF group compared to the RS group (p<0.05). In terms of peak sensory dermatome level, 80% of patients in the RF group reached T8, compared to 65% in the RS group. Additionally, the duration of sensory-motor block was significantly longer with prolonged postoperative analgesia in the RF group (p<0.05), with better overall anesthesia quality reported. Both groups maintained hemodynamic stability with no difference in side effect between both group. Conclusion: The findings of our study strongly support the use of a low dose of hyperbaric ropivacaine combined with fentanyl for spinal anesthesia in elderly patients undergoing mesh hernioplasty. This combination offers rapid onset, superior quality of anesthesia, and a lack of side effects, reinforcing its effectiveness in elderly patients.
In elderly patients, neuraxial anaesthesia remains a well-accepted and safe technique of anaesthesia in infra-umbilical surgery. It significantly reduces perioperative pulmonary complications, surgical stress response, and enhances postoperative analgesia, thus preventing deep venous thrombosis.(1) This is particularly beneficial in a population that is more prone to perioperative complications due to reduced physiological reserve and associated cardiovascular comorbidity.
Recent research has shifted the focus of spinal anaesthesia from traditional methods to using low doses of local anaesthetics combined with lipophilic opioids.(2,3) This combination is effective for pain relief because LAs and intrathecally opioids work together to enhance pain control and haemodynamic stability in elderly patients.(4)
Ropivacaine, a well-established local anaesthetic structurally related to Bupivacaine, plays a significant role in spinal anaesthesia. Its hyperbaric solution, a recent introduction, is designed to reduce potential toxicity, improve haemodynamic stability, and enhance block characteristics, thereby improving patient outcomes.(5)
Owing to its low lipid solubility, the blockade of sensory fibres is more intense than motor fibres.(6)
Fentanyl is the most commonly used intrathecally lipophilic opioid. A 10–30 mcg dose takes effect quickly (in about 10–20 minutes) and lasts 4–6 hours, with minimal spread toward the head. Thus, it reduces the risk of delayed respiratory depression, making intrathecal fentanyl ideal for elderly patients, where intense pain relief without extended hospital stay is important.(7)
In the present study, we used fentanyl as an adjunct to Ropivacaine in neuraxial blocks because it is a short-acting opioid, is readily available, and is extensively used to prolong postoperative analgesia. We will compare the clinical efficacy and safety of hyperbaric 0.75% Ropivacaine (2 ml) with and without 10 ug of fentanyl and assess the suitability of heavy Ropivacaine for elective mesh hernioplasty surgeries in elderly patients. Your expertise and experience are invaluable in this process.
This randomized, double-anonymized study was conducted with the approval of the Institutional Ethics Committee. Written informed consent was obtained from all study participants. We enrolled eighty patients ASA Ι- ΙΙ, aged 60 to 70 years, scheduled for elective unilateral meh hernioplasty under spinal anaesthesia. Patients with refusal, a history of pre-existing cardio-pulmonary diseases, neurological and renal dysfunction, coagulopathy, spinal deformity, and hypersensitivity to local anaesthetic agents will be excluded.
Computer-generated numbers randomized patients into two groups, each of 40. Group RP received ropivacaine heavy 0.75% 2 ml with NS 0.2 ml, a total of 2.2 ml, while group RF received ropivacaine heavy. 75% 2 ml with Inj. fentanyl 0.2 ml, a total 2.2 ml volume. To ensure blinding, another anesthesiologist, not involved in the study, meticulously prepared the drugs. A commercially available hyperbaric preparation of Roipvacaine was used (Ropin Heavy, 75% neon laboratory).
The day before the scheduled surgery, a pre-anaesthetic evaluation was done, and patients were instructed to take the bedtime tablet ranitidine. After overnight fasting, patients were shifted to the operating room on the day of surgery, and preloading was done with a balanced salt solution of 10 ml/kg. After the baseline parameter was obtained, patients were put in a lateral position, followed by a lumbar puncture at the L3-L4 subarachnoid space with a 25 G quinces spinal needle. Once a clear flow of cerebrospinal fluid is established, the study drug solution will be administered within 15 seconds, followed by patients kept supine with no tilt. The following parameters, such as HR, SBP, DBP, and SPO2, will be recorded for 1 min, 3 min after every 5 min until 30 min, followed by every 15 min until completion of surgery. The level of sensory blockade was tested using a pinprick test with a 25G hypodermic needle in the midclavicular line bilaterally, and the onset of sensory anaesthesia (T10 level sensory block) and peak sensory Dermatome block, time to reach peak sensory level, and L1 regression will be recorded. The duration of the sensory block is defined as the period from the onset of the sensory block to L1 regression. The degree of motor blockade will be assessed by the bromage score onset of motor (bromage M3) and duration of motor block defined as the period from the onset of motor blockade (bromage score M3) to recovery to complete motor power (bromage score M0). When an adequate sensory block is achieved, surgery is initiated. In the case of patient anxiety and discomfort, an intravenous midazolam (0.02-0.05 mg/kg) bolus with fentanyl (1-2 ug/kg) will be administered. Hypotension, defined as a decrease in mean arterial blood pressure of more than 20% of the basal pre-anaesthetic value, will be managed with a bolus dose of in. mephentermine 6 mg. Bradycardia will be defined as a heart rate <50 beats per minute and treated with atropine 0.5 mg. Respiratory depression is defined as a respiratory rate of 10/min and oxygen saturation <90%.
As detailed in the study sheet, side effects such as hypotension, bradycardia, nausea, vomiting, and pruritus were anticipated, and measures were in place to manage them effectively, ensuring the safety and comfort of the patients.
The statistical analysis was conducted using Microsoft Excel for data management and the Statistical Package for Social Sciences (SPSS) version 20 for rigorous analysis. Categorical data (qualitative) was presented as numbers (proportion) and compared using the chi-square test, a standard method known for its precision. Continuous variables (quantitative) were presented as mean SD, analysed, and compared using a t-test, another standard method that ensures precision. A significance level of p <0.05, a standard in the field, was used to determine statistical significance.
This study, we evaluated the effects of two anesthetic techniques, RF and RP, on sensory and motor blockade in elderly patients undergoing mesh hernioplasty. Key demographic variables were comparable between both groups (table 1) The findings revealed that the RF group had a significantly shorter sensory onset time (1.96 min) and a longer total sensory duration (275.63 min) compared to the RP group (<0.05) Additionally, the RF group achieved complete motor blockade earlier (3.68 min) and experienced a prolonged duration of motor blockade (274.75 min) compare to Ropivacaine alone group (table 2). The time to peak dermatome block (T8) was also earlier in the RF group (4.87 min) (table 2). Furthermore, 80% of the RF group reached the peak sensory level of T8, while only65% in the RP group reach T8 dermatome level. Duration of effective postoperative analgesia was longer in RF group compare to RP group (p< 0.05) with overall quality of analgesia was Excellent in the RF group, with no patients requiring supplementary analgesics, unlike seven patients in the control group(table 3). Hemodynamic parameters remained comparable between both groups, and no patient required mephentermine or oxygen therapy. In our study, we noted that side effects commonly associated with fentanyl, including nausea, vomiting, pruritus, and respiratory depression, were not reported. (Table 4)
Table 1: Demographic profile
Parameter |
Group RP (n=40) |
Group RF 9 (n=40) |
P value |
Age (year) |
66.08 ± 12.58 |
66.63 ± 12.01 |
0.77 |
Weight (kg) |
63.10 ± 8.97 |
64.30 ± 7.92 |
0.4 |
Height (cm) |
171.03 ±5.64 |
169.82 ± 4.57 |
0.1 |
Duration of surgery (min) |
57.40 ± 18.97 |
48.68 ± 15.82 |
0.2 |
Note are expressed as mean± standard deviation, P<0.05 significant
Table 2. Spinal Block Characteristics of Spinal Block
Parameters |
Group RP(n=40) |
Group RF (n=40) |
P value |
Sensory onset time (min) |
2.45±1.10 |
1.96± 0.59 |
0.01 |
Motor onset time (Bromage sore(min) |
4.42± 1.92 |
3.68±0.94 |
0.03 |
Time to reach peak sensory dermatome block (min) |
5.63±1.31 |
4.87±1.08 |
0.0059 |
Time to S1 regression (min) |
245.25±29.08 |
275.63±19.34 |
0.01 |
Duration of motor Block (min) |
224.18±34.97 |
274.75±41.07 |
0.0001 |
Note .Value are measured mean± sandard deviation, P<0.05 significant
Table 3. Efficacy of spinal anesthesia
|
Group RP(n=40) |
Group RF (n=40) |
Quality of intraoperative analgesia |
|
|
Excellent |
28(70%) |
40 (100%) |
Good |
6(15%) |
0 |
Fair |
3(7.5%) |
0 |
Poor |
3(7.5%) |
0 |
Intraoperative analgesic supplementation |
7(17.5%) |
0 |
Time to first request of analgesic (min) |
245.25±29.08* |
288.63±19.34 |
Note. Data are expressed as n (%) or mean ± SD, P* <0.05
Table 4. Side -effect
|
Group RP(n=40) |
Group RF (n=40) |
Bradycardia |
1 (0.25) |
2 (0.5) |
Hypotension |
0 (0.0) |
0(0.0) |
Nausea |
2 (0.5) |
3(0.75) |
Pruritus |
0 (0.0) |
1(0.25) |
Shivering |
3 (0.75) |
2 (0.5) |
Respiratory depression |
0 (0.0) |
0 (0.0) |
Note .data are expressed as n (%)
Recent studies have shifted the focus of spinal anaesthesia (SA) from traditional methods to utilizing low doses of local anaesthetics (LA) in combination with lipophilic opioids. The synergistic effects of local anaesthetics and intrathecal opioids for pain relief are well established. This combination can provide effective analgesia while potentially extending the duration of postoperative pain relief without causing significant motor blockage.(8,9) Notably, using a lower dose of local anaesthetic can decrease the likelihood of hemodynamic complications in elderly patients, effectively mitigating associated risks.(10) Research by Carpenter et al. highlighted that both high levels of sensory anaesthesia and older age are major contributors to the risk of spinal hypotension In older adults, the incidence of hypotension associated with spinal anaesthesia ranges from 25% to 69%.(11) Factors such as reduced physiological reserve and an increased prevalence of systemic conditions, particularly cardiovascular issues, render the elderly more susceptible to long-term complications from even short episodes of untreated hypotension.(12,13)
Building on this knowledge, the integration of fentanyl with hyperbaric ropivacaine was explored because earlier studies indicated a ceiling effect with doses exceeding 12.5 micrograms. This approach aims to optimize anesthesia effectiveness while potentially minimizing side effects in elderly popultion. (14)
In our study we investigate the efficacy fentanyl – Ropivacaine combination versus Ropivacaine alone in mesh hernioplasty Mesh hernioplasty that required the T10 segments for the proper height of the sensory block typically lasts within one hour.
In preesent addition of fentanyl to hyperbaric ropivacaine in increase the intraoperative and postoperative quality of anesthesia. The combination of 0.75% ropivacaine and 10 μg of fentanyl demonstrates a notable improvement in the speed of sensory and motor block onset during subarachnoid blockade, offering a promising enhancement over the use of ropivacaine alone in this study. The effectiveness of intrathecalropivacaine changes significantly when combined with opioids. A compelling study by Yegin et al. demonstrated that adding intrathecal fentanyl to ropivacaine for transurethral resection of the prostate not only prolonged the duration of the block but also extended the time before patients requested analgesia for the first time (15)
The use of intrathecal fentanyl has been found to significantly early sensory motor onset, prolong the recovery of sensory block and duration of complete analgesia were significantly longer n fentanyl group compare to the control group. These effects of combination of fentanyl - Ropivacaine are consistent with previous studies, which also reported similar outcomes when fentanyl was used in combination with Ropivacaine or Bupivacaine. (14,16,17)
In this study, we also observed that peak sensory level of T8 was reached in 80% of the RF group, compared to 65% in the control group. Nonetheless, all patients in both groups attained the T10 dermatomal level necessary for mesh hernioplasty. It’s important to acknowledge that 30% of patients in the Ropivacaine-only group required supplementary analgesia and sedation, suggesting that the addition of fentanyl enhances the quality of anesthesia in mesh hernioplasty.
Utilizing lower doses of local anesthetics can help restrict the spread of spinal blocks; however, these reduced doses may not achieve sufficient sensory blockage. To improve analgesic effects and ensure effective spinal anesthesia, adjuvants such as opioids are often employed due to their synergistic properties. Fentanyl, in particular, has become a popular choice as an adjuvant to local anesthetics, as it enhances pain relief without significantly increasing motor or sympathetic blockade associated with spinal anesthesia. This approach contributes to a decreased likelihood of hypotension, facilitates quicker recovery, and allows for earlier patient mobilization.(18)
In our study, we noted that side effects commonly associated with fentanyl, including nausea, vomiting, pruritus, and respiratory depression, were not reported. This absence of side effects may be attributed to the low dose of 10 micrograms administered.
Furthermore, we observed that both groups maintained hemodynamic stability, likely due to the use of low-dose heavy Ropivacaine, which has been demonstrated to be a more cardio-stable local anesthetic than Bupivacaine.
There is a significant lack of relevant data when comparing low-dose Ropivacaine heavy with fentanyl in mesh hernioplasty, particularly in elderly patients.
In conclusion, our research has shown that the addition of 10ug fentanyl to 15 m 0.75% Ropivacaine heavy in elderly patients undergoing mesh hernioplasty significantly improves the quality of anaesthesia and prolongs the duration of analgesia. Importantly, this combination a found to have minimal side effects, further reinforcing its safety profile. Additionally this combination was superior to Ropivacaine alone, making it promising option for anaesthesia in elderly patients.
1. Rasmussen LS. Postoperative cognitive dysfunction: incidence and prevention. Best Pract Res Clin Anaesthesiol. (2006) 20:315–30. doi: 10.1016/j.bpa.2005.10.011
2. Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. (2016) 2:CD000521. doi: 10.1002/14651858.CD000521.pub3
3. Gwirtz KH, Young JV, Byers RS, Alley C, Levin K, Walker SG, et al. The safety and efficacy of intrathecal opioid analgesia for acute postoperative pain: seven years’ experience with 5969 surgical patients at Indiana University Hospital. AnesthAnalg. (1999) 88:599–604.
4. Gupta S, Sampley S, Kathuria S. Intrathecalsufentanil or fentanyl as adjuvants to low dose bupivacaine in endoscopic urological procedures. J Anaesthesiol Clin Pharmacol. (2013) 29:509–15. doi: 10.4103/0970-9185. 119158
5. Hansen TG. Ropivacaine: A pharmacological review. Expert Rev Neurother 2004;4:781-91.
6. Singh I, Gupta M, Mahawar B, Gupta A. Comparison of effect of intrathecalsufentanil-bupivacaine and fentanyl-bupivacaine combination on postoperative analgesia. Indian J Anaesth 2008;52:301-4.
7. Kararmaz A, Kaya S, Turhanoglu S, Ozyilmaz MA. Low-dose bupivacainefentanyl spinal anaesthesia for transurethral prostatectomy. Anesthesia (2003) 58:526–30. doi: 10.1046/j.1365-2044.2003.03153.
8. Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. (2016) 2:CD000521. doi: 10.1002/14651858.CD000521.pub3
9. Gwirtz KH, Young JV, Byers RS, Alley C, Levin K, Walker SG, et al. The safety and efficacy of intrathecal opioid analgesia for acute postoperative pain: seven years’ experience with 5969 surgical patients at Indiana University Hospital. AnesthAnalg. (1999) 88:599–604.
10. Gupta S, Sampley S, Kathuria S. Intrathecalsufentanil or fentanyl as adjuvants to low dose bupivacaine in endoscopic urological procedures. J AnaesthesiolClinPharmacol. (2013) 29:509–15. doi: 10.4103/0970-9185. 119158
11. Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology (1992) 76:906–12. doi: 10.1097/00000542-199206000-00006
12. Critchley LAH. Hypotension, subarachnoid block and the elderly patient. Anaesthesia (1996) 5:1139–43. doi: 10.1111/j.1365-2044.1996.tb 15051.x 10. Moore DC, Bridenbaugh LD. Spinal (subarachnoid) block. A review of 11 574 cases. J Am Med Assoc. (1995) 195:123–8
13. Critchley LAH. Hypotension, subarachnoid block and the elderly patient. Anaesthesia (1996) 5:1139–43. doi: 10.1111/j.1365-2044.1996.tb 15051.
14. Chu CC, Shu SS, Lin SM, Chu NW, Leu YK, Tsai SK, Lee TY. The effect of intrathecal bupivacaine with combined fentanyl in cesarean section. ActaAnaesthesiol Sin 1995;33:149-154
15. Yegin A, Sanli S, Hadimioglu N, Akbas M, Karsli B. Intrathecal fentanyl added to hyperbaric ropivacaine for transurethral resection of the prostate. ActaAnaesthesiolScand 2005;49: 401-5.
16. Dahlgren G, Hultstrand C, Jakobsson J, Norman M, Eriksson EW, Martin H. Intrathecalsufentanil, fentanyl, or placebo added to bupivacaine for cesarean section. AnesthAnalg 1997; 85: 1288—93
17. Belzarena SD. Clinical effects of intrathecally administered fentanyl in patients undergoing cesarean section. AnesthAnalg 1992; 74: 653—7.
18. Ozgurel O. Comparison of fentanyl added to ropivacaine or bupivacaine in spinal anesthesia. RegAnesth Pain Med 2003; 28 (5 Suppl. 1),23:Abs 89.