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

NCT05491187 | Completed Phase 3 DMC

• 1 other identifier: Ra$@
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Visceral Pain

Outcome Measures

Primary Outcomes (1)

• To compare the incidence of intraoperative visceral pain between two groups

  For assessment of visceral pain, numerical pain rating scale of 0-10 is used for every patients.

  Assessment of visceral pain will done intraoperatively mainly during delivery of baby, exteriorization of uterus,handling of intraperitoneal organs like bowels, adenexa,suturing of visceral peritoneum during cesarean section.

Secondary Outcomes (5)

• To compare the intraoperative systolic blood pressure, diastolic blood pressure, mean arterial pressure in millimeter of mercury between two groups.

  Intraoperative period and also post operative time for upto 6 hour

• To compare intraoperative heart rate in beats per minute between 2 groups

  Intraoperative period and also post operative time for upto 6 hour

• To compare intraoperative oxygen saturation (SpO2) between 2 groups

  Intraoperative period and also post operative time for upto 6 hour

• To compare the incidence of side effects like nausea, vomiting, respiratory depression, level of sedation, pruritus between two groups

  Intraoperative period and also post operative time for upto 6 hour

• To assess the APGAR score of baby

  Observed within 1 and 5 minute after delivery of baby

Study Arms (2)

Group B (bupivacaine group)

ACTIVE COMPARATOR

Drug used: 0.5% hyperbaric bupivacaine heavy (8%dextrose) dose -11mg with volume of 2.2ml single administration, no repetition of intervention

Drug: 0.5% bupivacaine heavy

Group BF(bupivacaine with fentanyl group)

EXPERIMENTAL

Drug used:- 0.5% hyperbaric bupivacaine heavy (8%dextrose) dose -10mg, 2ml and fentanyl 10mg ,0.2ml with total volume of of 2.2ml single administration, no repetition of intervention

Drug: 0.5% bupivacaine heavy with fentanyl

Interventions

0.5% bupivacaine heavy DRUG

Spinal anesthesia with 0.5% bupivacaine heavy at L3-L4 intervertebral space using Quincke's spinal needle in sitting position, single administration for each patient

Also known as: Anawin Heavy 0.5%

Group B (bupivacaine group)

0.5% bupivacaine heavy with fentanyl DRUG

Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl at L3-L4 intervertebral space using Quincke's spinal needle in sitting position, single administration for each patient

Also known as: anawin heavy 0.5% + Trofentyl

Group BF(bupivacaine with fentanyl group)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since the study involve only pregnant women undergoing cesarean delivery, so eligible participant will be only female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA PS II
• Elective cesarean deliveries under SAB
• Age ≥18 years
• Term pregnancy ≥37 weeks of gestation
• Height ≥ 150 cm

You may not qualify if:

• Patients with neurological, psychiatric, cardiopulmonary, hepatorenal diseases, coagulopathy
• Patient refusal to participate
• Allergy or hypersensitivity to bupivacaine or fentanyl
• Patients with communication problem

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, Nepal

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• Bupivacaine-sparing effect of fentanyl in spinal anesthesia for cesarean delivery, In 2000, Choi et al.published double blinded, prospective study involving 120 parturients undergoing cesarean delivery.
• Spinal anesthesia for elective cesarean section. Bupivacaine associated with different doses of fentanyl: randomized clinical trial

MeSH Terms

Conditions

Visceral Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Biswas Pradhan, MBBS,MD FCTA

  Manmohan Cardiothoracic Vascular and Transplant Center, Institute of Medicine,TU,Nepal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be randomly distributed in the two groups using computed generated numbers that will be concealed in sequentially numbered, opaque sealed envelopes. The envelopes will be opened by an attending nurse not involved in the study just before the procedure. The study drug will be prepared by the attending anesthesiologist/ resident who will perform the subarachnoid block. The assessment of pain and data collection, data analysis will be done by principle investigator who is blinded to procedure. Thus, the patients and investigating and analyzing personal will be blinded to the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident, Anesthesiology

Model Details: Participants are assigned to study where two groups of treatments B and BF are given so that one group receives only B while another group receives only BF for the duration of study.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: September 20, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)