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Completed

NCT Number: NCT07516717

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Caracas

Caracas, Miranda, 1040, Venezuela

About this study

This prospective, randomized, double-blind controlled trial was designed to compare the analgesic efficacy and safety of two doses of intrathecal morphine (75 mcg versus 100 mcg) in patients undergoing elective cesarean delivery under spinal anesthesia. A total of 240 ASA physical status II patients schedule for elective cesarean delivery were enrolled and randomly assigned into two parallel groups. Patients received either 75 mcg or 100 mcg of intrathecal morphine as part of a standardized spinal anesthesia technique using local anesthetic. Randomization was performed using a predefined allocation method, and both patients and outcome assessors were blinded to group assignment. Perioperative management was standardized across both groups to minimize confounding variables. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at 2, 4, 8, 12 and 24 hours following surgery. The primary outcome was VAS pain score at 24 hours. Secondary outcomes included pain scores at earlier time points, requirement for rescue analgesia, incidence of opioid-related adverse effects (nausea, vomiting, pruritus), and neonatal outcomes assessed by Apgar scores. The objetive of this study was to determinethe optimal intrathecal morphine dose that provides effective postoperative analgesia while minimizing adverse effects in the obstetric population. The study was conducted in accordance with institutional ethical standards and approved by the corresponding ethics committee.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal morphine

Drug

Intrathecal administration of preservative-free morphine sulfate at doses of 75 mcg or 100 mcg as part of spinal anesthesia for elective cesarean delivery. The drug is administered once at the time the spinal anesthesia to provide postoperative analgesia.

Other names: Morphine sulfate

Primary outcomes

  1. Postoperative pain intensity at 24 hours

    Time frame: 24 hours after cesarean delivery

    Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain. Measurements will be recorded at 2, 4, 8, 12 and 24 hours after surgery. The primary endpoint is the VAS score at 24 hours.

Secondary outcomes

  1. Total opioid consumption within 24 horas

    Time frame: 0 - 24 hours after surgery

    Total supplemental opioid requirement (e.g., tramadol or morphine equivalents) during the first 24 hours postoperatively.

  2. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: 0 - 24 hours after surgery.

    Number of patients experiencing nausea and/or vomiting requiring treatment.

  3. Incidence of pruritus

    Time frame: 0 - 24 hours after surgery.

    Number of patients reporting clinically significant itching requiring treatment.

  4. Time to first rescue analgesia

    Time frame: 0 - 24 hours after surgery.

    Time elapsed from spinal anesthesia to first request for additional analgesia.

  5. Neonatal outcome

    Time frame: at birth (1 and 5 minutes)

    Apgar scores assessed at 1 and 5 minutes after birth

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Caracas

Other

Registry information

Official study title

Efficacy and Safety of Two Doses of Intrathecal Morphine (75 mcg Versus 100mcg) for Postoperative Analgesia After Elective Cesarean Section: A Prospective, Randomized, Double-blind Controlled Trial

Acronym: ITM-CESAREAN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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