Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
ID07386353

Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial

Led by Hospital Central do Funchal · Updated on 2026-02-04

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Cesarean section is a common surgical procedure worldwide, and managing acute postoperative pain effectively is crucial in obstetric anesthesiology. Researchers are evaluating whether intrathecal morphine provides better pain relief after elective cesarean delivery compared to the standard epidural morphine. This randomized clinical trial aims to clarify the optimal opioid administration route to support faster maternal recovery, newborn care, and safe breastfeeding. Pregnant women undergoing elective cesarean section will be randomly assigned to receive either intrathecal morphine at a dose of 80 mcg or epidural morphine given as a 2.5 mg bolus at the end of surgery, followed by another 2.5 mg bolus 24 hours later. The study focuses on comparing the effectiveness of these two analgesia methods during the first 24 hours after surgery. Participants will be monitored for pain levels during the first 24 and 48 hours after surgery, need for additional pain medication, sedation levels, nausea, vomiting, itching, impact of pain on movement and activities, and overall satisfaction with pain management. All evaluations will assess safety and comfort during recovery, with the primary outcome being pain control at 24 hours post-cesarean. The trial is conducted at Hospital Central do Funchal and lasts through the initial postoperative period.

CONDITIONS

Brief Title

Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women scheduled for elective cesarean section
  • Age over 18 years
  • Willingness to participate with signed informed consent
Not Eligible

You will not qualify if you...

  • American Society of Anesthesiologists (ASA) physical status classification over III
  • Chronic kidney disease with glomerular filtration rate below 60 mL/min
  • Known allergies to medications used in the study
  • Opioid tolerance
  • Contraindication to neuraxial anesthesia techniques

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 48 hours

Participants receive postoperative analgesia with either intrathecal morphine or epidural morphine following cesarean section.

1 visit during surgery and 1 follow-up visit within 48 hours postoperatively

Trial Site Locations

Total: 1 location

1

Hospital Central do Funchal

Funchal, Madeira, Portugal, 9004-514

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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