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

PHASE4RecruitingINTERVENTIONAL
Enrollment

1,312

Participants

Timeline

Start Date

July 15, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

June 30, 2027

Conditions
Caesarean SectionPostoperative Pain
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.

Trial Locations (8)

2100

NOT_YET_RECRUITING

Copenhagen University Hospital - Rigshospitalet, Copenhagen

2650

NOT_YET_RECRUITING

Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Hvidovre

2730

NOT_YET_RECRUITING

Copenhagen University Hospital - Herlev and Gentofte, Herlev, Herlev

3400

NOT_YET_RECRUITING

Copenhagen University Hospital - North Zealand, Hillerød, Hillerød

4000

RECRUITING

Zealand University Hospital, Roskilde

5000

NOT_YET_RECRUITING

University Hospital of Southern Denmark - Odense University Hospital, Odense C

6000

RECRUITING

University Hospital of Southern Denmark - Lillebælt Hospital, Kolding, Kolding

8200

NOT_YET_RECRUITING

Aarhus University Hospital, Aarhus

All Listed Sponsors
lead

Anne Juul Wikkelsø

OTHER