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

Phase 4

Not yet recruiting

• Conditions: Caesarean Section; Postoperative Pain
• Interventions: Drug: Intrathecal Morphine; Drug: Placebo (Sodium Chloride Injection, 0.9%)

• Registration Number: NCT06797973
• Lead Sponsor: Zealand University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-06-01
• Primary Completion: 2027-05-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1312

Inclusion Criteria

• Patients ≥ 18 years
• Singleton pregnancy
• Scheduled for planned caesarean section performed under spinal anaesthesia
• Written informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine	Intrathecal Morphine	Participants allocated to the intervention group will receive 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.
Placebo	Placebo (Sodium Chloride Injection, 0.9%)	Participants allocated to the control group will receive placebo consisting of 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.

Primary Outcome Measures

Name	Time	Method
Level of pain when mobilising from supine to sitting position within 24 hours	6, 12, 18 and 24 hours following spinal anaesthesia	Longitudinal measurements of NRS (0-10) at 6, 12, 18 and 24 hours with most focus on the 24-hour pain level
Maternal and neonatal serious adverse events	Within 7 days from discharge	Binary composite outcome: 1. Death of either participant or neonate within 7 days; 2. Participants with clinically significant respiratory depression within 24 hours, defined as respiratory depression documented in the electronic medical record, e.g. need for airway management or pharmacological intervention (subjective assessment by treating clinician, validated by 2 investigators); 3. Neonates needing admission to neonatal intensive care unit within 48 hours; 4. Hospitalisation of either participant or neonate within 7 days after discharge; 5. Participants with severe vomiting or nausea within 24 hours, defined as ≥5 points on the 'Simplified postoperative nausea and vomiting impact scale'63 at any time point (6, 12, 18 and 24 hours)

Secondary Outcome Measures

Name	Time	Method
Opioid consumption within 24 hours	Within 24 hours following spinal anaesthesia	Mg oral morphine equivalents
Obstetric quality of recovery score at 24 hours	Within 24 hours following spinal anaesthesia	Obs-QoR-10 (0-100)
Morphine associated adverse effects within 24 hours	Within 24 hours following spinal anaesthesia	Binary composite outcome: participants experiencing either: 1. Vomiting (patient reported, yes/no); 2. Nausea; 3. Dizziness; 4. Pruritus Nausea, dizziness, and pruritus is assessed as "none", "little", "moderate", or "severe" with patients reporting "moderate" or "severe" categorised as having a positive outcome; 5. Urinary retention, defined as need for re-catheterisation within 24 hours
Participants satisfaction with postoperative pain-treatment during the first 24 hours	Within 24 hours following spinal anaesthesia	NRS 0-10
Established breastfeeding at 30 days	30 days from surgery	Proportion of neonates being exclusively breastfed at 30 days

Trial Locations

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