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

NCT06797973 | Recruiting Phase 4 DMC

• 1 other identifier: 2024-518678-16-00
• Study Type: interventional
• Target: 1,312
• Locations: 1 country
• Sites: 8

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.

Conditions

Caesarean Section; Postoperative Pain

Keywords

Caesarean section; Cesarean section; Cesarean delivery; Caesarean delivery; Postoperative pain; Intrathecal morphine; Spinal morphine; elective caesarean

Outcome Measures

Primary Outcomes (2)

• Level of pain when mobilising from supine to sitting position within 24 hours

  Longitudinal measurements of NRS (0-10) at 6, 12, 18 and 24 hours with most focus on the 24-hour pain level

  6, 12, 18 and 24 hours following spinal anaesthesia

• Maternal and neonatal serious adverse events

  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)

  Within 7 days from discharge

Secondary Outcomes (5)

• Opioid consumption within 24 hours

  Within 24 hours following spinal anaesthesia

• Morphine associated adverse effects within 24 hours

  Within 24 hours following spinal anaesthesia

• Obstetric quality of recovery score at 24 hours

  Within 24 hours following spinal anaesthesia

• Participants satisfaction with postoperative pain-treatment during the first 24 hours

  Within 24 hours following spinal anaesthesia

• Established breastfeeding at 30 days

  30 days from surgery

Other Outcomes (30)

• Serious adverse events, pain at 24 hours and opioid consumption, compared using Win Ratio

  Within 7 days from discharge

• Overall severity of pruritus within 24 hours

  Within 24 hours following spinal anaesthesia

• Pharmacological treatment for opioid-related adverse effects within 24 hours

  Within 24 hours following spinal anaesthesia

Study Arms (2)

Intrathecal morphine

EXPERIMENTAL

Drug: Intrathecal Morphine

Placebo

PLACEBO COMPARATOR

Drug: Placebo (Sodium Chloride Injection, 0.9%)

Interventions

Intrathecal Morphine DRUG

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

Intrathecal morphine

Placebo (Sodium Chloride Injection, 0.9%) DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anne Juul Wikkelsø: lead

Study Sites (8)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Copenhagen University Hospital - Herlev and Gentofte, Herlev

Herlev, 2730, Denmark

NOT YET RECRUITING

Copenhagen University Hospital - North Zealand, Hillerød

Hillerød, 3400, Denmark

NOT YET RECRUITING

Copenhagen University Hospital - Amager and Hvidovre, Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

University Hospital of Southern Denmark - Lillebælt Hospital, Kolding

Kolding, 6000, Denmark

RECRUITING

University Hospital of Southern Denmark - Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Anneline B Seegert, MD

CONTACT

+4547326397; ansee@regionsjaelland.dk

Anne J Wikkelsø, MD, PhD

CONTACT

+4547325046; awik@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Senior Consultant, PhD

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 29, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (8)