Spinal morphine to reduce pain after planned caesarean section

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pragmatic, randomized, double-blind, placebo-controlled multicenter trial comparing low-dose (80 µg) intrathecal morphine versus saline added to standard spinal anesthesia for planned caesarean section. All participants receive standard multimodal postoperative analgesia and may use oral morphine as needed, while researchers collect pain scores, side-effect questionnaires, and maternal and neonatal safety data from medical records and surveys. Co-primary outcomes are postoperative pain (numeric rating scale) and a composite maternal-neonatal safety outcome, with a planned enrollment of 1,312 participants to detect clinically relevant differences. The trial is investigator-initiated and designed to provide pragmatic evidence about the balance of benefits and harms of adding intrathecal morphine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients ≥ 18 years
* Singleton pregnancy
* Scheduled for planned caesarean section performed under spinal anaesthesia
* Written informed consent

Exclusion Criteria:

* Allergy to or contraindications towards trial medication
* Patients planned for postoperative epidural due to expected difficult postoperative pain management
* Patients planned for combined spinal-epidural as primary anaesthesia
* Inability to understand and read Danish
* Previous inclusion in the trial

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Copenhagen University Hospital - Rigshospitalet
  Copenhagen, Denmark Recruiting
• Copenhagen University Hospital - Herlev and Gentofte, Herlev
  Herlev, Denmark Recruiting
• Copenhagen University Hospital - North Zealand, Hillerød
  Hillerød, Denmark Recruiting
• Regional Hospital Horsens
  Horsens, Denmark Recruiting
• Copenhagen University Hospital - Amager and Hvidovre, Hvidovre
  Hvidovre, Denmark Recruiting

Study contacts

• Study coordinator: Anneline B Seegert, MD
• Email: ansee@regionsjaelland.dk
• Phone: +4547326397

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.