drugset / Trial / NCT05491187

Comparison Between Bupivacaine With and Without Fentanyl in Reducing Pain During Cesarean Delivery Under Spinal Anaesthesia

NCT05491187

RandomizedParallel-groupDouble-blindTreatment

Summary

Spinal anaesthesia with hyperbaric bupivacaine is the most commonly used anesthetic technique for cesarean section. Delivery of baby during cesarean section requires traction of peritoneum and handling of intraperitoneal organs resulting in intraoperative visceral pain. The incidence of this intraoperative visceral pain can be reduced with higher dose of hyperbaric bupivacaine (12-15mg), but increasing the dose of bupivacaine increases the risk of high sensory block resulting to major hemodynamic adverse events like hypotension, bradycardia or may lead to fetal distress. Neuraxial administration of fentanyl added to bupivacaine has been proposed to intensify the sensory block without increasing sympathetic block and also improves the quality of intraoperative analgesia thus, reduces the incidence of intraoperative visceral pain. Several studies have convincingly demonstrated efficacy of intrathecal fentanyl of different doses in improving the intraoperative analgesic effect along with its associated clinical effects. However, there has been limited research conducted to compare the analgesic effects of intrathecal fentanyl of low dose in reducing visceral pain in cesarean delivery especially in our setting. Therefore, in this study investigator aim to compare between hyperbaric bupivacaine alone with hyperbaric bupivacaine and fentanyl in reducing the visceral pain during cesarean sectionunder spinal anaesthesia. In this study, term parturient undergoing cesarean delivery in spinal anesthesia will be allocated in 2 groups. One group will receive intrathecal hyperbaric bupivacaine whereas another interventional group will receive hyperbaric bupivacaine with addition of fentanyl. Visceral pain will be assessed in both group using numerical pain rating scale along with monitoring of vitals. Data will be collected and will be filled up in a master chart in Microsoft Excel. Statistical analysis will be done.

Timeline

Start
2022-09-20
Primary completion
2023-04-13
Completion
2023-04-13

Publications

  • Results Ferrarezi, W.P.P., et al., Spinal anesthesia for elective cesarean section. Bupivacaine associated with different doses of fentanyl: randomized clinical trial. Braz J Anesthesiol, 2021. 71(6): p. 642-648. 2. Gebremedhn, E., T. Belayneh, and K. Abegaz, Analgesic Effect of Intrathecal Fentanyl as an Adjuvant to Spinal Anaesthesia in Comparison with Spinal Anaesthesia with Bupivacaine Only for Mothers Delivered by Emergency Cesarean Section. Journal of Anesthesia & Critical Care, 2017. 7: p. 1-9. 3. Choi, D.H., H.J. Ahn, and M.H. Kim, Bupivacaine-sparing effect of fentanyl in spinal anesthesia for cesarean delivery. Reg Anesth Pain Med, 2000. 25(3): p. 240-5. 4. Uppal, V. and D.M. McKeen, Strategies for prevention of spinal-associated hypotension during Cesarean delivery: Are we paying attention? Can J Anaesth, 2017. 64(10): p. 991-996. 5. Ben-David, B., et al., Low-dose bupivacaine-fentanyl spinal anesthesia for cesarean delivery. Reg Anesth Pain Med, 2000. 25(3): p. 235-9. 6. Goma, H.M., Spinal Additives in Subarachnoid Anaesthesia for Cesarean Section. 2014: IntechOpen. 7. Sia, A.T., et al., Use of hyperbaric versus isobaric bupivacaine for spinal anaesthesia for caesarean section. Cochrane Database Syst Rev, 2013(5): p. Cd005143. 8. Shafer, S.L.R.J.P.F.P., Stoelting's pharmacology and physiology in anesthetic practice. 2015. 9. Bogra, J., N. Arora, and P. Srivastava, Synergistic effect of intrathecal fentanyl and bupivacaine in spinal anesthesia for cesarean section. BMC Anesthesiology, 2005. 5(1): p. 5. 10. Ali, M.A., et al., A double-blind randomized control trial to compare the effect of varying doses of intrathecal fentanyl on clinical efficacy and side effects in parturients undergoing cesarean section. J Anaesthesiol Clin Pharmacol, 2018. 34(2): p. 221-226. 11. Uppal, V., et al., Efficacy of Intrathecal Fentanyl for Cesarean Delivery: A Systematic Review and Meta-analysis of Randomized Controlled Trials With Trial Sequential Analysis. Anesth Analg, 2020. 130(1): p. 111-125. 12. Pedersen, H., et al., Incidence of Visceral Pain during Cesarean Section: The Effect of Varying Doses of Spinal Bupivacaine. Anesthesia & Analgesia, 1989. 69(1): p. 46-49. 13. Williamson, A. and B. Hoggart, Pain: a review of three commonly used pain rating scales. J Clin Nurs, 2005. 14(7): p. 798-804. 14. Nisbet, A.T. and F. Mooney-Cotter, Comparison of selected sedation scales for reporting opioid-induced sedation assessment. Pain Manag Nurs, 2009. 10(3): p. 154-64. 15. Acharya, B., et al., Effect of low dose bupivacaine and fentanyl during elective cesarean section under spinal anesthesia Journal of Anesthesia & Clinical Research, 2019. 10: p. 1-6. 16. Edwards, R.R., Chapter 5 - Pain Assessment, in Essentials of Pain Medicine and Regional Anesthesia (Second Edition), H.T. Benzon, et al., Editors. 2005, Churchill Livingstone: Philadelphia. p. 29-34. 17. Pasero, C., Assessment of sedation during opioid administration for pain management. J Perianesth Nurs, 2009. 24(3): p. 186-90. 18. Caughey, A.B., et al., Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol, 2018. 219(6): p. 533-544.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 10 mg Intrathecal
Comparator Bupivacaine Other / unclassified 11 mg Intrathecal
Subject Fentanyl Other / unclassified 10 ug Intrathecal

Indications

No indication recorded.