European Journal of Cardiovascular Medicine

Spinal anaesthesia is the technique usually performed for urological, perineal, lower abdominal and lower limb surgeries. It is technically easier, has rapid onset of action and decreased failure rates. It is safe and economical.1,2 Patient is awake and conscious, so is able to describe and relate timely indicators of complications. Spinal anaesthesia is straightforward and rapid to learn and teach. It requires less experience and provides relief from pain of surgery for several hours as compared to general anaesthesia.3

Spinal anaesthesia using traditional local anaesthetics only, without adjuvants have a shorter duration of action and so leads to an early analgesic requirement in the postoperative period. In the context of augmentation strategies for neuraxial blockade, a number of intrathecal adjuvants have been used. This includes Opioids like Morphine, Fentanyl and Buprenorphine and Non-opioids like Midazolam, Ketamine, Neostigmine, Tramadol and Clonidine. Amongst them Opioids have been the most studied and commonly used drugs.4

Buprenorphine is a mixed agonist-antagonist narcotic with high affinity agonist effect in µ opiate receptors and antagonist effect at κ opiate receptors.5 Fentanyl, a lipophilic opioid, has rapid onset of action following administration as an additive with Local anaesthetic.4 The aim of the study was to compare 0.5% heavy bupivacaine with buprenorphine versus 0.5% heavy bupivacaine with fentanyl for lower abdominal and lower limb surgeries.

Present study was randomized comparative study, conducted in department of Anaesthesia

Inclusion criteria

·         Patients of age 18-60 years of age, under ASA (American Society of Anaesthesiology) physical status 1 and 2, undergoing lower abdominal and lower limb surgeries under spinal anaesthesia, willing to participate in present study

Exclusion criteria

·         Refusal by the patient.

·         Patients with ASA physical status 3 or more.

·         Patients posted for emergency surgeries and caesarean section.

·         Patients who are allergic to any of the test drugs (Allergy to local anaesthetics and opioids)

·         Local infection at the site of Lumbar puncture.

·         Contraindication to spinal anaesthesia (CNS infections, Coagulopathy, raised ICT, Spinal deformities, Hypovolaemic shock, Progressive neurodegenerative disorder etc.)

Study was explained to participants in local language & written informed consent was taken. All the patients were visited on the day prior to surgery, explained in detail about the anaesthetic procedure and informed written consent was obtained. The patients was kept nil orally 6 hrs. prior to the surgery.

On arrival to the operation theatre, following insertion of an 18-G venous cannula, 500mL of Ringer Lactate was infused to the patient before spinal anaesthesia. Standard monitors like ECG, Non-invasive Blood Pressure and SpO2 probe was attached and baseline heart rate, blood pressure, oxygen saturation recorded. Inj. Pantoprazole 40mg i.v and Inj. Metoclopramide 10m.g slow i.v half an hour before the surgery was administered.

Systematic random sampling technique in which 30 subjects were selected for each group.

·         Group B (n=30)- Hyperbaric Bupivacaine (0.5%) 2.5ml with buprenorphine 60 µg in 0.5 ml

·         Group F (n=30)- Hyperbaric Bupivacaine( 0.5%) 2.5ml with fentanyl 25 µg in 0.5ml

Patients were then positioned lateral decubitus and 0.5% heavy Bupivacaine 2.5ml along with either one of the adjuvants was administered in subarachnoid space at L3-L4 interspace through a standard midline approach using a 25G Quincke needle and all patients were supplemented with oxygen - 4L/min via a face mask throughout the procedure after approximating them to the surgical position.

Sensory block-Temperature sensation was assessed using ice pack method in the mid-axillary line on both sides, motor block was assessed using a modified Bromage scale. The highest dermatome level of sensory blockade and motor blockade was recorded. Recovery time for the sensory blockade was considered as two dermatome regression of anaesthesia from the maximum level; motor block duration was the time to return to grade 1 on the modified Bromage scale.

Postoperative pain was assessed by using the Visual Analog Scale (VAS 0 no pain and VAS 10 worst possible pain) at 4, 8, 12 and 24 hour. Patients with a VAS score of 3 or more was given Inj. Paracetamol 15mg/kg IV. The time of patient’s first request for postoperative analgesia after the surgery was recorded as duration of postoperative analgesia.

The vital data heart rate (HR),blood pressure(BP), mean arterial pressure (MAP), oxygen saturation (SpO2), respiratory rate (RR) was recorded immediately before and 60secs after dural puncture, every 10mins after spinal anaesthesia intraoperatively and every 15mins in the postoperative period.

All data were recorded using Microsoft Excel for Windows and statistical analysis was done using SPSS (Statistical Package for Social Science).Chi-square test and Student-t tests were used for test of significance and statistical difference. Unpaired t test applied to find the statistical significant between the groups. p value less than 0.05 considered statistically significant at 95% confidence interval.

All demographic data are comparable in all the 2 groups. The following table shows the age, height, weight, sex distribution, ASA physical status and duration of study from all the two groups.

Table 1: General characteristics

The vital data heart rate (HR),blood pressure(BP), mean arterial pressure (MAP), oxygen saturation (SpO2), respiratory rate (RR) was recorded immediately before and 60secs after dural puncture, every 10mins after spinal anaesthesia intraoperatively and every 15mins in the postoperative period. No statistically significant difference was noted at any time.

We compared mean sedation score between the group at same time period & no statistically significant difference was noted at any time.

Table 2: Comparison of mean sedation score between the group at same time period

           (p>0.05 no significant compared group-B with group-F)

We compared mean VAS score between the group at same time period & no statistically significant difference was noted at any time.

Table 3: Comparison of mean VAS score between the groups at same time period

            (*p<0.05 significant compared group-B with group-F)

In this study the mean highest level of Sensory block in Group B was 6.50±1.96 and in Group F was 7.26±2.18.The comparison was statistically significant. The Time to highest sensory level block in Group B was 9.72±2.91mins compared to Group F which was 8.43±2.56mins. The p value is 0.04 which is statistically significant.

In this study the comparison of mean highest motor block between the groups at same time period in Group F was 5.46±1.64 compared to Group B which was 4.06±1.10. The p value was 0.043 which statistically significant.

The comparison of mean time to post analgesia between the groups at same time period was 457.29±2.28 in Group B when compared to Group F was 361.88±3.26. The p value is 0.001 (p<0.05) which is highly significant.

Table 4: Comparison of mean time to post analgesia between the groups at same time period

In our study 1 patient from Group B developed Tachycardia. 2 patients developed nausea and 3 patients had vomiting .3 patients of Group F developed Pruritis compared to none in Group B. None of the patients in our study had significant hypotension in either of the groups. The percentage of side effects in patients in Group B was 3.33% compared to Group F which was 23.33%.

Table 5: Distribution of patients based on type of side effects

urological, perineal and lower limb surgeries requiring a block from T10-S4.6 Spinal anaesthesia is the technique of choice for these procedures as patients remain conscious; making it possible for early recognition of complications if any due to intrathecal procedure or surgery per se. Local anaesthetics were administered alone for providing anaesthesia for this procedure for several years. However, this contributed to considerable hemodynamic adverse effects in many patients. Also the need to prolong post- operative analgesia lead to addition of various adjuvants to intrathecal local anaesthetics.

After lower abdominal and lower limb procedures patients often suffer from pain. It is therefore important to ensure adequate postoperative analgesia. In order to achieve this, addition of adjuvants to intrathecal local anaesthetics came into practice. An ideal combination should provide adequate intraoperative anaesthesia, good extended postoperative analgesia without prolonging the motor blockade or producing adverse haemodynamic or respiratory consequences.

Since the first clinical use of intrathecal morphine in 1979, numerous studies have confirmed the efficacy of spinally-administered opioids for postoperative pain relief.7 However, opioids do not remain localised to the site of intrathecal injection. After spinal administration, opioids undergo redistribution by rostral spread, which explains the occurrence of nausea, vomiting and respiratory depression.7

The need for rescue analgesia was taken when the patient first complained of pain. The duration of analgesia was measured from the time of subarachnoid injection to the time of first rescue analgesia. The comparison of mean time to post analgesia between the groups at same time period was 457.29±2.28mins in Group B when compared to Group F was 361.88±3.26mins. The p value is 0.001 (p<0.05) which is highly significant.

Pal et al.,8 study on Intrathecal Buprenorphine, Clonidine and Fentanyl as Adjuvants to 0.5% Hyperbaric Bupivacaine in Lower Abdominal and Lower Limb Surgeries showed that Buprenorphine is another opioid which increases sensory block without affecting motor block and haemodynamics.

Saxena et al.,9 in his study showed that Fentanyl is a lipophilic μ receptor agonist opioid when given intrathecally it exerts its effect by combining with opioid receptor in the dorsal horn of spinal cord and may have a supraspinal spread and action. The effectiveness of Intrathecal opioids depends on their bioavailability, so opioids can provide good perioperative analgesia.

Chavan et al.,4 studies showed that two segment regression and the duration of analgesia was i.e.134.12±10.81 and 207±17.57 minutes respectively In the context of ‘Augmentation strategies’ for epidural and intrathecal analgesia, the discovery of opioid receptors and subsequent development of the technique of epidural and intrathecal opioid administration is undoubtedly one of the most significant advances in pain management of last four decades In this study with fentanyl 25 mcg as additive to bupivacaine, showed that quality of analgesia was good with minimal side effects.

The study conducted by Hassani et al.,10 on bupivacaine-sufentanil versus bupivacaine-fentanyl in spinal anesthesia of patients undergoing lower extremity surgery showed that the effective analgesia time for intrathecal fentanyl was 163±21mins and analgesia time was 168±28mins.The pain scores by VAS in the 1st hour was 3±1.2SD and in the 2nd hour was 4.6±1.6SD.

Biswas et al.,11 demonstrated that the duration of effective analgesia (time from injection to first parenteral analgesic) was increased with the dose of intrathecal fentanyl 12.5 microgram (248±11.76). Pruritus was only 15% in fentanyl group. The results of the study indicated that 12.5 microgram of fentanyl added with hyperbaric 0.5% bupivacaine for spinal anaesthesia would markedly improve intraoperative anaesthesia, and significantly reduced the demand for postoperative analgesic with good maternal satisfaction and fetal well-being.

Sunil Dixit12 experience on Intrathecal Buprenorphine showed that the Onset of analgesia was 5.35± 1.79 min in Control group, while 1.85 ± 1.39min in Study group. The total duration of analgesia was prolonged from 145.16 ± 25.86 mins in Control group to 491.26 ± 153.97mins in Study group and concluded that intrathecal Buprenorphine is a suitable drug for postoperative analgesia after caesarean section with no effects on neonatal Apgar scores with minimal side effects.

Nelamangala et al.,13 compared buprenorphine 100mcg and fentanyl 50 mcg as additives to bupivacaine 0.5% heavy 17.5mgfor lower limb orthopedic procedures and found that in buprenorphine group 24 hour analgesic requirements were significantly less with good VAS scores and minimal side effects in both the groups. Opioids may have additive or synergistic effect with local anaesthetics for postoperative pain relief and also may improve quality of anaesthesia Onset of sensory and motor blockade is comparable in both the groups. Onset is earlier in Fentanyl group (P<0.001) compared to buprenorphine group. But duration of analgesia (P<0.001) and duration of motor blockade is comparatively more with Buprenorphine group. Pain intensity was significantly lower with Buprenorphine group with Mean ± SD of 4.20±0.81 and p<0.001 comparing to Fentanyl group as evaluated by VAS score [9].

Safiya et al., 14 showed in the study of 0.5% bupivacaine with buprenorphine showed that 1 μg/kg Buprenorphine to a maximum of 50 μg when added to 15 mg of 0.5% heavy Bupivacaine intrathecally provides analgesia for 476.6±93.7 minutes [66].

Akanmu On et al.,15 found that addition of 25 μg of fentanyl to 10 mg of 0.5% hyperbaric bupivacaine intrathecally for open reduction and internal fixation of lower limb fractures significantly prolonged the duration of complete analgesia as well as effective analgesia thereby reducing the need for early postoperative analgesic use. [67].

On the whole time of onset of sensory and motor block was comparable with no significant hemodynamic or respiratory disturbances in both groups. Nausea and vomiting was observed in 5 patients of group F and tachycardia was observed in 1 patient of Group B .Duration of analgesia was significantly longer in group B compared to group F and hence duration was 457.29±2.28 mins in group B compared to 361.88±3.26mins in group F. Buprenorphine scored over fentanyl in offering better perioperative analgesia.

Prevention and treatment of postoperative pain plays an important role in reducing patient morbidity. It enables early ambulation, reduces morbidity, duration of hospital stay and improves the surgical outcome. The adequacy of postoperative pain control is one of the most important factors in determining safe discharge from Day care surgery.3

This study shows that the addition of Fentanyl or Buprenorphine to Intrathecal Hyperbaric Bupivacaine is safe as both maintain hemodynamic stability without producing excessive sedation or respiratory depression but Buprenorphine as adjuvant prolongs the duration of postoperative analgesia and the request for first analgesics. The patient’s well-being was satisfactory in both the groups. Further studies to validate our findings recruiting larger patient population is considered essential.

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