Spinal morphine to reduce pain after planned caesarean section

MOTHER Trial: Efficacy and Safety of Low-dose Intrathecal Morphine Following Planned Caesarean Section - a Randomised, Blinded, Clinical, Controlled, Multicentre Trial.

This trial will test whether adding a small dose of morphine to spinal anesthesia helps women having planned caesarean sections have less pain afterward without harming mother or baby.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1312 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Zealand University Hospital (other)
• Locations: 8 sites (Aarhus and 7 other locations)
• Trial ID: NCT06797973 on ClinicalTrials.gov

What this trial studies

This is a pragmatic, randomized, double-blind, placebo-controlled multicenter trial comparing low-dose (80 µg) intrathecal morphine versus saline added to standard spinal anesthesia for planned caesarean section. All participants receive standard multimodal postoperative analgesia and may use oral morphine as needed, while researchers collect pain scores, side-effect questionnaires, and maternal and neonatal safety data from medical records and surveys. Co-primary outcomes are postoperative pain (numeric rating scale) and a composite maternal-neonatal safety outcome, with a planned enrollment of 1,312 participants to detect clinically relevant differences. The trial is investigator-initiated and designed to provide pragmatic evidence about the balance of benefits and harms of adding intrathecal morphine.

Who should consider this trial

Good fit: Ideal candidates are adult women (≥18 years) with a singleton pregnancy scheduled for a planned caesarean under spinal anesthesia who can read Danish and give informed consent.

Not a fit: Patients planned for combined spinal‑epidural or a postoperative epidural, those with allergy or contraindication to morphine, and those unable to read Danish (including many emergency cesarean cases) are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding low-dose intrathecal morphine could reduce early postoperative pain and opioid use after caesarean, speeding recovery and supporting mother–infant bonding.

How similar studies have performed: Previous smaller trials and routine clinical use suggest intrathecal morphine gives up to 24 hours of improved analgesia after caesarean, but high-quality large randomized evidence on low-dose protocols and safety trade-offs is still limited.

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

Where this trial is running

Aarhus and 7 other locations

• Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
• Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark (NOT_YET_RECRUITING)
• Copenhagen University Hospital - Herlev and Gentofte, Herlev — Herlev, Denmark (NOT_YET_RECRUITING)
• Copenhagen University Hospital - North Zealand, Hillerød — Hillerød, Denmark (NOT_YET_RECRUITING)
• Copenhagen University Hospital - Amager and Hvidovre, Hvidovre — Hvidovre, Denmark (RECRUITING)
• University Hospital of Southern Denmark - Lillebælt Hospital, Kolding — Kolding, Denmark (RECRUITING)
• University Hospital of Southern Denmark - Odense University Hospital — Odense C, Denmark (RECRUITING)
• Zealand University Hospital — Roskilde, Denmark (RECRUITING)

Study contacts

• Study coordinator: Anneline B Seegert, MD

Conditions: Caesarean Section, Postoperative Pain, Caesarean section, Cesarean section, Cesarean delivery, Caesarean delivery, Postoperative pain, Intrathecal morphine