Clinical trial NCT06797973: Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Caesarean Section
Official title: MOTHER Trial: Efficacy and Safety of Low-dose Intrathecal Morphine Following Planned Caesarean Section - a Randomised, Blinded, Clinical, Controlled, Multicentre Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Caesarean Section
Postoperative Pain
Keywords: Caesarean section
Cesarean section
Cesarean delivery
Caesarean delivery
Postoperative pain
Intrathecal morphine
Spinal morphine
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 1312
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of pain when mobilising from supine to sitting position within 24 hours
timeFrame: 6, 12, 18 and 24 hours following spinal anaesthesia
measure: Maternal and neonatal serious adverse events
timeFrame: Within 7 days from discharge
Secondary outcomes:
measure: Opioid consumption within 24 hours
timeFrame: Within 24 hours following spinal anaesthesia
measure: Morphine associated adverse effects within 24 hours
timeFrame: Within 24 hours following spinal anaesthesia
measure: Obstetric quality of recovery score at 24 hours
timeFrame: Within 24 hours following spinal anaesthesia
measure: Participants satisfaction with postoperative pain-treatment during the first 24 hours
timeFrame: Within 24 hours following spinal anaesthesia
measure: Established breastfeeding at 30 days
timeFrame: 30 days from surgery
Other outcomes:
measure: Serious adverse events, pain at 24 hours and opioid consumption, compared using Win Ratio
timeFrame: Within 7 days from discharge
measure: Overall severity of pruritus within 24 hours
timeFrame: Within 24 hours following spinal anaesthesia
measure: Pharmacological treatment for opioid-related adverse effects within 24 hours
timeFrame: Within 24 hours following spinal anaesthesia
measure: Ability to mobilise independently
timeFrame: 6, 12, 18 and 24 hours following spinal anaesthesia
measure: Level of pain at rest within 48 hours
timeFrame: 6, 12, 18, 24 and 48 hours following spinal anaesthesia
measure: Opioid consumption within 48 hours
timeFrame: Within 48 hours following spinal anaesthesia
measure: "Rescue" supplemental pain treatment with truncal nerve block or epidural within 24 hours
timeFrame: Within 24 hours following spinal anaesthesia
measure: Level of pain when mobilising from supine to sitting position at 48 hours
timeFrame: Within 48 hours following spinal anaesthesia
measure: Total consumption of non-opioid analgesic medication (paracetamol, NSAIDs) within 24 hours and 48 hours
timeFrame: Within 24 and 48 hours following spinal anaesthesia
measure: Intraoperative nausea, vomiting and pruritus
timeFrame: During surgery
measure: Overall severity of pain within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall severity of nausea/vomiting within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall severity of dizziness within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall severity of shivering within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall feeling of being comfortable within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall ability to mobilise independently within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall ability to independently hold infant within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall ability to nurse/feed infant independently within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall ability to handle personal hygiene within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Overall feeling of being in control within 24 hours (ObsQoR-10)
timeFrame: Within 24 hours following spinal anaesthesia
measure: Length of hospital stay
timeFrame: Within 7 days from discharge
measure: Readmission or unplanned hospital re-attendance within 7 days
timeFrame: Within 7 days following surgery
measure: Failed or insufficient spinal anaesthesia
timeFrame: Within 24 hours following spinal anaesthesia
measure: Hospital-free days within 7 days
timeFrame: Within 7 days following surgery
measure: Ogilvie's syndrome/ileus within 7 days
timeFrame: Within 7 days following surgery
measure: Apgar score at 5 minutes following birth
timeFrame: 5 minutes following birth
measure: Apgar score <7 at 5 minutes following birth
timeFrame: 5 minutes following birth
measure: Neonatal need for respiratory support within 48 hours
timeFrame: Within 48 hours following birth
measure: Neonatal sedation resulting in failed breast-/bottle feeding within 48 hours
timeFrame: 24 and 48 hours following birth
measure: Neonatal hospitalisation within 24 hours after discharge
timeFrame: 24 hours after discharge
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Rigshospitalet
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev and Gentofte, Herlev
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital - North Zealand, Hillerød
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital - Amager and Hvidovre, Hvidovre
city: Kolding
country: Denmark
facility: University Hospital of Southern Denmark - Lillebælt Hospital, Kolding
city: Odense C
country: Denmark
facility: University Hospital of Southern Denmark - Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
References: