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

NCT07516717 | Completed Phase 4

• 1 other identifier: HUC-ITM-2023-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section; Obstetric Anesthesia; Postoperative Pain

Keywords

intrathecal morphine; spinal anesthesia; cesarean delivery; postoperative analgesia; opioid side effects; visual analog scale

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity at 24 hours

  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.

  24 hours after cesarean delivery

Secondary Outcomes (5)

• Total opioid consumption within 24 horas

  0 - 24 hours after surgery

• Incidence of postoperative nausea and vomiting (PONV)

  0 - 24 hours after surgery.

• Incidence of pruritus

  0 - 24 hours after surgery.

• Time to first rescue analgesia

  0 - 24 hours after surgery.

• Neonatal outcome

  at birth (1 and 5 minutes)

Study Arms (2)

Intrathecal Morphine 75 mcg

EXPERIMENTAL

Participants receive a single intrathecal dose of 75 mcg morphine during spinal anesthesia for elective cesarean delivery.

Drug: Intrathecal Morphine

Intrathecal Morphine 100 mcg

EXPERIMENTAL

Participants receive a single intrathecal dose of 100 mcg morphine during spinal anesthesia for elective cesarean delivery.

Drug: Intrathecal Morphine

Interventions

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.

Also known as: Morphine sulfate

Intrathecal Morphine 100 mcg; Intrathecal Morphine 75 mcg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Caracas: lead

Study Sites (1)

Hospital Universitario de Caracas

Caracas, Miranda, 1040, Venezuela

Location

Related Links

• Non-opioid analgesics for chronic postsurgical pain
• Optimal dose of intrathecal morphine for cesarean delivery
• ERAS Society recommendations for cesarean delivery
• Intrathecal morphine dose in total hip surgery

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Joseph a Veraza, Md

  Hospital Universitario de Caracas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and outcomeassessors were blinded to group allocation. Intrathecal morphine dose were prepared in identical syringes to ensure cincealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Operating Room And Anesthesiologist

Model Details: Patients were randomly assigned to one of two parallel groups to recieve either 75 mcg or 100 mcg of intrathecal morphine as part of spinal anesthesia for elective cesarean delivery. Each participant received a single assigned intervention with no crossover betweenn groups.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: January 7, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 17, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

VE (1)