CompletedPhase 4

Intrathecal Morphine 75 mcg Versus 100 mcg for Post-Cesarean Analgesia: A Randomized Double-blind Trial

Venezuela240 participantsStarted 2023-01-07

Plain-language summary

This study evaluates the efficacy and safety of two different doses of intrathecal morphine (75 mcg versus 100 mcg) for postoperative analgesia in patients undergoing elective cesarean delivery under spinal anesthesia. Effective postoperative pain control is essential to improve maternal recovery, facilitate early mobilization, and enhance neonatal care. Participants were randomly of assigned to receive either 75 mcg or 100 mcg of intrathecal morphine dose that provides effective analgesia while minimizing adverse effects in the obstetric population.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant women scheduled for elective cesarean delivery under spinal anesthesia. * Age between 18 and 45 years. * ASA physical status II * Singleton term pregnancy. * Ability to provide written informed consent. Exclusion Criteria: * Contraindications to spinal anesthesia. * Known allergy or hypersensitivity to morphine or opioids. * Chronic opioid use or opioid dependence. * Significant systemic disease (ASA more or equal to III). * Pregnancy complications (e.g., preeclampsia, eclampsia). * Body mass index more than 40 kg/m2. * Infection at the puncture site. * Coagulopathy or anticoagulant therapy. * Refusal to participate.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain intensity at 24 hours

Timeframe: 24 hours after cesarean delivery

Trial details

NCT IDNCT07516717

SponsorHospital Universitario de Caracas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

View on ClinicalTrials.gov More Postoperative Pain trials