RecruitingPhase 4NCT06797973

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.


Sponsor

Anne Juul Wikkelsø

Enrollment

1,312 participants

Start Date

Jul 15, 2025

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

DRUGIntrathecal 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

DRUGPlacebo (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

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NCT06797973


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