Effects of different doses of fentanyl combined with bupivacaine in spinal anesthesia elective cesarean section: a randomized clinical trial in the Palestinian obstetrics practice

Phase 2

Completed

• Conditions: Cesarean section deliveries; Cesarean; Spinal anesthesia; Bupivacaine; Fentanyl

• Registration Number: TCTR20220430008
• Lead Sponsor: An-Najah National University

Brief Summary

The women who received 25 mcg of fentanyl with 7.5 mg of hyperbaric bupivacaine had significantly shorter sensory block latency, longer duration of sensory block, longer duration of analgesia, less need for rescue analgesia, expressed higher satisfaction with analgesia, experienced less hemodynamic instabilities, and experienced fewer episodes of bradycardia and vomiting compared to those who received bupivacaine alone or in combination with lower doses of fentanyl.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-10-31
• Study Start: 2022-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

1) being at least 18 years old, 2) full-term pregnancy (at least 37 weeks), 3) pregnant with a single fetus, 4) being scheduled for caesarian delivery under spinal anesthesia, 5) American Society of Anesthesiologists (ASA) physical class I and II, and 6) providing written informed consent.

Exclusion Criteria

Women who had a history of sensitivity/allergy for local anesthetics and opioids, psychiatric disorders, drug addiction, pregnancy complications, fetal distress, and/or those who could not provide written informed consent were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure at 2, 4, and 6 min noninvasive blood pressure monitor,Heart rate at 2, 4, and 6 min pulse oximeter,1)Sensory block latency every min Bromage score

Secondary Outcome Measures

Name	Time	Method
duration of analgesia every min VNS