Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Caesarean Section, Postoperative Pain
In brief
The goal of this clinical trial is to learn if morphine added to the spinal anaesthesia can improve postoperative pain treatment for patients undergoing caesarean section, without increasing the risk of serious adverse events in mother and baby. The main questions it aims to answer are: * Is the treatment effective in preventing postoperative pain? * Is the treatment safe for both mother and baby? Participants will be given a normal spinal anaesthesia with addition of either morphine or sodium chloride (inactive substance). All participants will receive standard postoperative pain treatment, including morphine tablets as needed. Researchers will collect data from the electronic medical record and ask the participants to fill out questionnaires about pain levels and possible side effects.
Key facts
- Study ID
- NCT06797973
- Run by
- Anne Juul Wikkelsø
- People needed
- 1312
- Starts
- 2025-07-15
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2025-12-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients ≥ 18 years
- Singleton pregnancy
- Scheduled for planned caesarean section performed under spinal anaesthesia
- Written informed consent
You may not qualify if…
- 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 is running
- Zealand University Hospital — Roskilde, Denmark (enrolling)
- University Hospital of Southern Denmark - Lillebælt Hospital, Kolding — Kolding, Denmark (enrolling)
- University Hospital of Southern Denmark - Odense University Hospital — Odense C, Denmark (enrolling)
- Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Copenhagen University Hospital - Amager and Hvidovre, Hvidovre — Hvidovre, Denmark (enrolling)
- Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark
- Copenhagen University Hospital - Herlev and Gentofte, Herlev — Herlev, Denmark
- Copenhagen University Hospital - North Zealand, Hillerød — Hillerød, Denmark
Full record on ClinicalTrials.gov
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