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ACTIVE NOT RECRUITING
NCT07144410

Pain Control and Side Effects in Cesarean Section Anesthesia: Comparison of Intrathecal Morphine and Fentanyl

Sponsor: University of Oradea

View on ClinicalTrials.gov

Summary

Intrathecal opioids are frequently combined with local anesthetics to optimize spinal anesthesia for cesarean delivery. Fentanyl, a lipophilic opioid, offers rapid onset and enhanced intraoperative analgesia. However, its postoperative analgesic duration is limited, but in contrast, morphine, a hydrophilic opioid, provides prolonged postoperative pain control but has a slower onset and a higher incidence of adverse effects, notably nausea and vomiting. This prospective, randomized, double-blind, parallel study enrolled 180 parturients scheduled for elective cesarean section, all receiving spinal anesthesia with hyperbaric bupivacaine (7.5-10 mg, adjusted to height) plus either intrathecal fentanyl 25 µg (F group) or intrathecal morphine 100 µg and fentanyl 25µg (M+F group). Primary outcomes include intraoperative and postoperative pain scores, systemic opioid consumption, and patient satisfaction, while secondary outcomes assess the incidence of opioid-related side effects.

Official title: Balancing Analgesia and Side Effects: Intrathecal Fentanyl and Morphine Versus Fentanyl for Cesarean Section Anesthesia

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2025-08-01

Completion Date

2025-10

Last Updated

2025-08-27

Healthy Volunteers

Yes

Interventions

DRUG

fentanyl + morphine

The purpose of the trial is to study the quality of anaesthesia and perioperative analgesia provided by fentanyl, morphine and bupivacaine versus fentanyl and bupivacaine, as well as their side effects.

DRUG

fentanyl

The purpose of the trial is to study the quality of anaesthesia and perioperative analgesia provided by fentanyl, morphine and bupivacaine versus fentanyl and bupivacaine, as well as their side effects.

Locations (1)

University of Oradea, Pelican Clinic Hospital

Oradea, Bihor County, Romania