A COMPARISON OF THE ANALGESIC EFFICACY AND SAFETY OF EPIDURAL PLAIN BUPIVACAINE ALONE WITH PLAIN BUPIVACAINE AND TRAMADOL IN LOWER LIMB ORTHOPAEDIC SURGERIES.
Background: Tramadol, a centrally acting opioid-like drug with analgesic effect and fewer side-effects than the typical opioids, has been administered through various routes including epidural route. Pain management is necessary based on humanitarian ground as well as for therapeutic reasons. Failure to relieve pain may lead to tachycardia, hypertension, hypoxia, restlessness, nausea and vomiting, increase in metabolism and sleep disturbances in the patient. Pain control remains the key to post-operative recovery of orthopaedic surgical patients and therefore, optimizing post-operative analgesia improves the patient’s ability to fully participate in rehabilitative sessions.
There are various adjuvant drugs that have been added to bupivacaine to modify its action and these include among others tramadol, morphine and fentanyl. The sensory blockade effect of epidural anaesthesia has been used for intra-operative and post-operative pain management in surgeries involving the lower limbs and pelvis. This study therefore, was aimed at comparing the analgesic efficacy and safety of epidural 0.5 % plain bupivacaine alone and epidural 0.5 % plain bupivacaine and tramadol as an additive in lower limb orthopaedic surgeries.
Methods: This is a prospective randomized double blind controlled study involving seventy four (74) ASA I and II patients scheduled for elective lower limb orthopaedic surgeries. The patients were allocated into two groups. Group A (n=37) received 19mls of 0.5% plain bupivacaine with 1 ml of water for injection epidurally at L3-L4 inter-space, while group B received 19mls of 0.5% plain bupivacaine with 1ml (50mg) of tramadol at L3-L4 epidurally. No premedication was given to all the patients that were recruited for this study.
Standard monitoring of the vital signs was done. The researcher was involved in the recording of the pain assessment with Visual Analogue Scale (VAS), blood pressure, heart rate, respiratory rate, and oxygen saturation at intervals.
The quality of block, duration of analgesia and side effects of epidural anaesthesia was also noted. The duration of analgesia was defined as time from administration of local analgesic to first analgesic request or when the VAS scores ≥ 4.
Results: Results showed that the mean onset time of sensory block was 37.03± 3.43 min and 24.32±3.76 min in group A and B respectively, with statistically significant difference (P < 0.01).The mean duration of analgesia was 189.05±21.92 min and 254.19±32.78 min in groups A and B respectively, which was also statistical significant difference (P <0.01).
The variation of intra-operative VAS scores in the two groups did not show any statistical significant difference between groups A and B (P > 0.05). There was no statistical significant difference over time in heart rate, blood pressure, respiratory rate and oxygen saturation.
The grades of motor block and maximum sensory block height was no statistical significant difference (P=0.26) in the study groups.
The common side effects observed were bradycardia, hypotension, nausea and vomiting. However, the incidence was no statistical significant difference between the two groups (P<0.05). Hypotension was observed in 6 (16.2%) patients and 9 (24.3%) patients in group A and B respectively, (p=0.47). While, bradycardia was observed in 5 (13.5%) patients and 7 (18.9%) patients in group A and B respectively (p= 0.68), nausea and vomiting was observed in 5 (13.5%) patients and 7 (18.9%) patients in groups A and B respectively, (P= 0.68).
Conclusion: The addition of 50mg (1ml) of tramadol to plain bupivacaine for epidural analgesia prolonged the duration of analgesia and improved the quality of analgesia when compared to the use of bupivacaine alone. However, there were no statistically significant differences in the side effects/complications among the two groups.