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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAnne Juul Wikkelsø

About this trial

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

Qualifiers

Patients ≥ 18 years

Singleton pregnancy

Scheduled for planned caesarean section performed under spinal anaesthesia

Written informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intrathecal Morphine
  • Placebo (Sodium Chloride Injection, 0.9%)

Treatment groups

1,312 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Anne Juul Wikkelsø

Lead sponsor

Zealand University Hospital

Sponsor institution