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 range18 Years – 45 Years

SexFEMALE

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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.

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