MedTrace Logo

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

NCT07144410 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-08-27

No results posted yet for this study

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.

Conditions

  • Anaesthesia, Spinal

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.

Sponsors & Collaborators

  • Oradea Pelican Clinic Hospital

    collaborator UNKNOWN

  • University of Oradea

    lead OTHER

Principal Investigators

  • Aurel Mohan, MD, PhD · Head of Surgery Department of Medicine and Pharmacy Faculty of Oradea

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144410 on ClinicalTrials.gov