Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section
MOTHER Trial: Efficacy and Safety of Low-dose Intrathecal Morphine Following Planned Caesarean Section - a Randomised, Blinded, Clinical, Controlled, Multicentre Trial.
Anne Juul Wikkelsø
1,312 participants
Jul 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Patients ≥ 18 years
- Singleton pregnancy
- Scheduled for planned caesarean section performed under spinal anaesthesia
- Written informed consent
Exclusion Criteria5
- 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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Interventions
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
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)
View Full Details on ClinicalTrials.gov
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NCT06797973