Persistent Pain After Cesarean Delivery – A Danish Multicenter Cohort Study

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Description

In Denmark, around 12,700 patients undergo Cesarean delivery (CD) annually, constituting approximately 20% of all childbirths in the country. Worldwide, the number is increasing each year, with more than 20 million CD performed annually.

Postoperative pain after CD is typically moderate to severe in intensity and still constitutes a significant challenge, balancing effective pain relief and potential side effects. Correlations between moderate to severe acute pain and the development of persistent pain after CD is still unclear.

Postsurgical persistent pain is a significant, often unrecognized clinical problem that causes distress and diminishes the quality of life for patients. Despite advances in understanding the factors contributing to persistent postsurgical pain and an increased focus on identifying patients at risk, the management and prevention of postsurgical persistent pain are still inadequate.

It is important to gain further insights into this population, and we have a unique opportunity to do so by following the national cohort from the ongoing Danish multicenter cohort study on pain after cesarean section (ClinicalTrials.gov Identifier: NCT06012747) over an extended follow-up period.

This involves continued prospective registration of Patient-Reported Outcome Measures (PROM) collected by SMS-based questionnaires in the months and years after the CD, thereby investigating the occurrence of both acute and persistent pain after CD.

The outcomes are focused on pain levels, the impact of pain on physical function and neuropathic pain characteristics in the months and years following the CD. The study also aims to explore the relationship between persistent and acute pain.

Study Overview

Start Date
September 1, 2023
Completion Date
December 31, 2029
Enrollment
300
Date Posted
February 8, 2024
Gender
Female

Locations

Full Address
Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
Hillerød 3400, Denmark

Eligibility

Study Population
Patients, aged > 18 years, who undergo planned cesarean delivery under spinal anesthesia.
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Patients who, after participating in the Danish multicenter cohort study on pain after cesarean delivery (ClinicalTrials.gov Identifier: NCT06012747), consent to continue to receive questionnaires about persistent pain.
Planned cesarean delivery in spinal anesthesia
Patients who speak and read Danish
Patients with a smartphone that can receive an SMS with a link to a questionnaire that can be opened online.

Exclusion Criteria:

• <18 years of age

Study Contact Info

Study Contact Name
Patricia Duch, MD; Helene Nedergaard, MD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
The Study Protocol is attached in full-text (Study Documents).
NCTid (if applicable)
NCT06247852