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NCT06797973 | NOT YET RECRUITING | Caesarean Section

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

Zealand University Hospital

Information provided by (Responsible Party):

Anneline Borchsenius Seegert

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.

Condition or disease

Caesarean Section

Postoperative Pain

Intervention/treatment

Intrathecal Morphine

Placebo (Sodium Chloride Injection, 0.9%)

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 1312 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : MOTHER Trial: Efficacy and Safety of Low-dose Intrathecal Morphine Following Planned Caesarean Section - a Randomised, Blinded, Clinical, Controlled, Multicentre Trial.
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2027-05-31
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Caesarean Section

Location Details

NCT06797973

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Denmark,

Aarhus University Hospital

Aarhus, Denmark, 8200

Not yet recruiting

Denmark,

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark, 2100

Not yet recruiting

Denmark,

Copenhagen University Hospital - Herlev and Gentofte, Herlev

Herlev, Denmark, 2730

Not yet recruiting

Denmark,

Copenhagen University Hospital - North Zealand, Hillerød

Hillerød, Denmark, 3400

Not yet recruiting

Denmark,

Copenhagen University Hospital - Amager and Hvidovre, Hvidovre

Hvidovre, Denmark, 2650

Not yet recruiting

Denmark,

University Hospital of Southern Denmark - Little Belt Hospital, Kolding

Kolding, Denmark, 6000

Not yet recruiting

Denmark,

University Hospital of Southern Denmark - Odense University Hospital

Odense C., Denmark, 5000

Not yet recruiting

Denmark,

Zealand University Hospital

Roskilde, Denmark, 4000