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Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section
Sponsor: Anne Juul Wikkelsø
Summary
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.
Official title: MOTHER Trial: Efficacy and Safety of Low-dose Intrathecal Morphine Following Planned Caesarean Section - a Randomised, Blinded, Clinical, Controlled, Multicentre Trial.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1312
Start Date
2025-07-15
Completion Date
2027-06-30
Last Updated
2025-12-19
Healthy Volunteers
No
Conditions
Interventions
Intrathecal Morphine
80 μg preservative-free morphine (0.2 ml) added to a single-shot spinal anaesthesia consisting of 11.5 mg hyperbaric bupivacaine and 10 μg fentanyl
Placebo (Sodium Chloride Injection, 0.9%)
0.2 ml of isotonic sodium chloride added to a single-shot spinal anaesthesia consisting of 11.5 mg hyperbaric bupivacaine and 10 μg fentanyl.
Locations (8)
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark
Copenhagen University Hospital - Herlev and Gentofte, Herlev
Herlev, Denmark
Copenhagen University Hospital - North Zealand, Hillerød
Hillerød, Denmark
Copenhagen University Hospital - Amager and Hvidovre, Hvidovre
Hvidovre, Denmark
University Hospital of Southern Denmark - Lillebælt Hospital, Kolding
Kolding, Denmark
University Hospital of Southern Denmark - Odense University Hospital
Odense C, Denmark
Zealand University Hospital
Roskilde, Denmark