Obstetric Anaesthesia Cluster
The MOTHER project
Postoperative pain management using low-dose intrathecal morphine for non-urgent caesarean section.
Project Status:
Planned
Background
About half of women who give birth via caesarean section experience severe postoperative pain. Inadequate pain management can impair early mother-child bonding, complicate breastfeeding and delay recovery after surgery.
A single dose of morphine added to the spinal anaesthesia (intrathecal morphine) can provide pain relief for up to 24 hours and may offer superior pain management and increased patient satisfaction compared to pain management with systemic opioids. The treatment is standard treatment in many countries, and recommended in several guidelines, but the evidence for the treatment is of low quality.
The MOTHER trial aims to answer two central questions
1. Is treatment with low-dose intrathecal morphine, in combination with standard multimodal analgesia, effective in preventing postoperative pain in patients undergoing caesarean section?
2. Is the treatment safe for both mother and baby?
Intervention
1,312 patients undergoing planned caesarean section will be randomised 1:1 to either:
B
0.2 ml placebo (isotonic sodium chloride) added to the normal spinal anaesthesia consisting of bupivacaine and fentanyl
A
80 µg intrathecal morphine (0.2 ml) added to the normal spinal anaesthesia consisting of bupivacaine and fentanyl
All trial participants will receive standard multimodal postoperative analgesia.
Study design
The MOTHER trial is a superiority, investigator-initiated, pragmatic, randomised, blinded, placebo-controlled multicentre trial. The trial will take place at 8 Danish hospitals.
The two co-primary outcomes are:
1. Pain scores (NRS 0-10) at 6, 12, 18 and 24 hours following surgery
2. A binary composite safety-outcome: maternal and neonatal death, maternal respiratory depression, neonatal NICU admission, maternal and neonatal hospitalisation within 7 days from discharge and maternal severe vomiting and nausea.
The secondary outcomes are opioid consumption, morphine-associated adverse effects, obstetric quality of recovery-score (ObsQoR-10), satisfaction with pain treatment and established breastfeeding at 30 days.