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RECRUITING
NCT06797973
PHASE4

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

Sponsor: Anne Juul Wikkelsø

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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