Morphine hydrochloride for Postoperative pain following elective caesarean section

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years\n- Singleton pregnancy\n- Scheduled for elective caesarean section performed under spinal anaesthesia\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Allergy to or contraindications towards trial medication\n- Patients planned for postoperative epidural due to expected difficult postoperative pain management\n- Patients planned for combined spinal-epidural as primary anaesthesia\n- Inability to understand and read Danish\n- Previous inclusion in the trial"}

Primary endpoints

• {"endpoint_text":"- Level of pain when mobilising from supine to sitting position within 24 hours: Level of pain when mobilising from supine to sitting position within 24 hours","definition_or_measurement_approach":"Pain level when mobilising from supine to sitting position measured within 24 hours after surgery (time window: within 24 hours)."}
• {"endpoint_text":"- Maternal and neonatal safety: Binary composite outcome consisting of 1) participants with respiratory depression 2) participants with severe nausea/vomiting within 24 hours 3) neonatal admission within 48 hours 4) hospitalisation of participant or neonate within 7 days after discharge and 5) death of either participant or neonate within 7 days","definition_or_measurement_approach":"Composite binary outcome; components assessed with specified time windows: respiratory depression; severe nausea/vomiting within 24 hours; neonatal admission within 48 hours; hospitalisation of participant or neonate within 7 days after discharge; death of participant or neonate within 7 days."}

Secondary endpoints

• {"endpoint_text":"- Opioid consumption within 24 hours","definition_or_measurement_approach":"Opioid consumption measured within 24 hours postoperatively."}
• {"endpoint_text":"- Morphine associated adverse events within 24 hours: Vomiting, nausea, dizziness, pruritus and urinary retention","definition_or_measurement_approach":"Occurrence of listed adverse events within 24 hours."}
• {"endpoint_text":"- Obstetric quality of recovery score at 24 hours","definition_or_measurement_approach":"Obstetric quality of recovery score assessed at 24 hours."}
• {"endpoint_text":"- Participants satisfaction with postoperative pain-treatment during the first 24 hours","definition_or_measurement_approach":"Participant satisfaction with postoperative pain treatment during the first 24 hours."}
• {"endpoint_text":"- Established breastfeeding at 30 days","definition_or_measurement_approach":"Breastfeeding status assessed at 30 days postoperatively."}

Denmark

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

315

Number Of Sites

9

Number Of Participants

1312

Primary sponsor

Full Name

Region Sjaelland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsor duties (code: 1); contact email: gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Hospital/Clinic/Other health care facility"}