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NCT Number: NCT07386353

Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Central do Funchal

Funchal, Madeira, 9004-514, Portugal

Location status: Recruiting

Location contact

Joao Salgado Costa

CONTACT

[email protected]

+351914633659

João Salgado Costa

PRINCIPAL_INVESTIGATOR

About this study

This unicentric randomized clinical trial aims to determine whether intrathecal morphine provides superior postoperative analgesia compared with epidural morphine during the first 24 hours following cesarean section. The study population will consist of pregnant women undergoing elective cesarean delivery at Hospital Central do Funchal.

Participants will be randomly assigned to one of two groups. One group will receive postoperative analgesia with intrathecal morphine (80 mcg). The second group will receive epidural morphine, administered as a 2.5 mg bolus at the end of surgery, followed by an additional 2.5 mg bolus 24 hours postoperatively.

The primary outcome will be the assessment of pain during the first 24 postoperative hours. Secondary outcomes will include pain assessment during the first 48 hours, the need for rescue analgesia, levels of sedation, incidence of nausea and vomiting, pruritus, the impact of pain on mobilization and other activities, and overall maternal satisfaction.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Intrathecal morphine

Drug

Postoperative analgesia with intrathecal morphine 80 mcg

Epidural Morphine

Drug

Postoperative analgesia with epidural morphine 2.5mg

Primary outcomes

  1. Postoperative pain control

    Time frame: Evaluation at 24 hours after surgery

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

Secondary outcomes

  1. Total rescue opioid consumption

    Time frame: Evaluation at 24 hours and 48 hours after surgery

  2. Adverse effects associated with analgesia

    Time frame: Evaluation at 24 hours and 48 hours after surgery

    To evaluate adverse effects associated with intrathecal versus epidural morphine administration, namely sedation, nausea, vomiting, and pruritus.

  3. Patients satisfaction with analgesia

    Time frame: Evaluation at 24 hours and 48 hours after surgery

    Evaluated using the satisfaction-related items of the PAIN OUT questionnaire, scored on a Numeric Rating Scale.

  4. Postoperative pain control

    Time frame: Evaluation at 48 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Hospital Central do Funchal

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 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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