Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia

NCT07386353 | Recruiting Phase 4 DMC

• 1 other identifier: E24060638
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section is one of the most commonly performed surgical procedures worldwide, making effective management of acute postoperative pain a key issue in obstetric anesthesiology. Post-cesarean analgesia should promote rapid maternal recovery, support newborn care, and consider the pharmacological implications for breastfeeding. According to recent PROSPECT® guidelines from ESRA, neuraxial opioids play a central role in post-cesarean analgesia and are at least as effective as other techniques, such as continuous local anesthetic infusion. However, the optimal route of opioid administration remains unclear. While earlier studies favored epidural morphine, more recent evidence suggests that intrathecal morphine may provide superior analgesia. Due to limited and conflicting data, no definitive conclusion can be drawn. Given that epidural morphine remains standard practice at Hospital Central do Funchal, a randomized clinical trial is proposed to compare the analgesic efficacy of intrathecal versus epidural morphine after elective cesarean section.

Conditions

Analgesia Obstetrical; Analgesia; Post Operative Pain; Patient Satisfaction; Cesarean Section Pain

Keywords

Post-Cesarean Analgesia; Epidural Morphine; Intrathecal Morphine

Outcome Measures

Primary Outcomes (1)

• Postoperative pain control

  Comparison between intrathecal morphine versus epidural morphine analgesia assessed using the Numeric Rating Scale (NRS) as part of the PAIN OUT questionnaire.

  Evaluation at 24 hours after surgery

Secondary Outcomes (4)

• Total rescue opioid consumption

  Evaluation at 24 hours and 48 hours after surgery

• Adverse effects associated with analgesia

  Evaluation at 24 hours and 48 hours after surgery

• Patients satisfaction with analgesia

  Evaluation at 24 hours and 48 hours after surgery

• Postoperative pain control

  Evaluation at 48 hours after surgery

Study Arms (2)

Intrathecal morphine

EXPERIMENTAL

Postoperative analgesia with intrathecal morphine 80 mcg

Drug: Intrathecal Morphine

Epidural morphine

EXPERIMENTAL

Postoperative analgesia with epidural morphine 2.5mg

Drug: Epidural Morphine

Interventions

Epidural Morphine DRUG

Postoperative analgesia with epidural morphine 2.5mg

Epidural morphine

Intrathecal Morphine DRUG

Postoperative analgesia with intrathecal morphine 80 mcg

Intrathecal morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women scheduled for elective cesarean section;
• Age \> 18 years;
• Willingness to participate in the study, as demonstrated by signed informed consent.

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status classification \> III;
• Chronic kidney disease with a glomerular filtration rate \< 60 mL/min;
• Relevant drug allergies (particularly to protocol medications);
• Opioid tolerance;
• Contraindication to neuraxial anesthetic techniques.

Sponsors & Collaborators

• Hospital Central do Funchal: lead

Study Sites (1)

Hospital Central do Funchal

Funchal, Madeira, 9004-514, Portugal

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Patient Satisfaction

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 4, 2026
• Study Start: May 20, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

PT (1)