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Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section

RecruitingPhase 4Ages 18 Years - anyFemaleAnne Juul Wikkelsø
NCT06797973 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intrathecal Morphine
  • Placebo (Sodium Chloride Injection, 0.9%)
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Where

9 sites
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
Regional Hospital Horsens
Horsens, 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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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