Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section
NCT ID: NCT06797973
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1312 participants
INTERVENTIONAL
2025-07-15
2027-06-30
Brief Summary
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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
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Caesarean section is surgical procedure associated with moderate to severe postoperative pain, which can negatively affect recovery, mother-child bonding and the initiation of breastfeeding. Intrathecal morphine may offer pain relief for up to 24 hours, and is widely implemented and recommended as part of multimodal postoperative pain management. Despite the widespread use, there is limited evidence for the balance between benefits and harms of low-dose intrathecal morphine in patients undergoing caesarean section.
The objective of the trial is to evaluate analgesic efficacy as well as maternal and neonatal safety associated with addition of low-dose (80 µg) intrathecal morphine versus placebo to standard multimodal postoperative pain management in patients undergoing planned caesarean section.
The trial is a superiority, investigator-initiated, pragmatic, randomised, blinded, placebo-controlled multicentre trial.
TRIAL SIZE: A total of 1,312 participants is required to show/reject a 35% relative increase in the composite co-primary safety outcome, with an estimated baseline incidence of 21% without intrathecal morphine and a power of 80%. We adjust statistically for having two primary outcomes by using an alpha of 2.5%. We reach a power of 99.9% for the co-primary outcome of pain score with an estimated mean Numeric Rating Scale (0-10) of 4.88, standard deviation of 2.0 and relevant mean difference of 1.0.
ETHICAL CONSIDERATIONS: Intrathecal morphine for caesarean delivery represents a common medical practice which is not supported by robust evidence. High-quality data on efficacy and safety of the treatment will enable clinicians to tailor postoperative pain treatment to each patient, thus improving care for future patients. Choosing low-dose morphine minimises the risk of adverse effects, and all trial participants will receive standard multimodal pain treatment. There is no evidence of any harmful neonatal effects. All trial participants will give informed consent, and the trial will adhere to the Declaration of Helsinki as well as national and international standards of good clinical practice.
PLANNED SUBSTUDIES:
* Incidence of desaturation and bradypnea during the first 24 hours following surgery, assessed using continuous wireless respiratory monitoring in a subpopulation of 100 patients at 3 trial sites.
* Efficacy and safety of intrathecal morphine in participant subgroups: The influence of different pre-existing factors on the primary outcomes
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intrathecal morphine
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
Placebo
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Scheduled for planned caesarean section performed under spinal anaesthesia
* Written informed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Anne Juul Wikkelsø
OTHER
Responsible Party
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Anne Juul Wikkelsø
Associate Professor, Senior Consultant, PhD
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Deepti Jain, MD
Role: primary
Kim Ekelund, MD, PhD
Role: primary
Kim Lindelof, MD, PhD
Role: backup
Kim Wildgaard, MD, PhD
Role: primary
Patricia Duch, MD
Role: primary
Maria E Kromann, MD, PhD
Role: primary
Helene K Nedergaard, MD, PhD
Role: primary
Mette L Andersson
Role: primary
Anne J Wikkelsø, MD, PhD
Role: primary
Other Identifiers
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2024-518678-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
2024-518678-16-00
Identifier Type: -
Identifier Source: org_study_id