Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

NCT06247852 | Completed DMC

• 1 other identifier: 101
• Study Type: observational
• Target: 477
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section Complications; Cesarean Section; Cesarean Delivery; Persistent Pain; Chronic Pain; SMS; Questionnaire

Keywords

persistent pain; chronic pain; Danish cohort; cesarean section; cesarean delivery; acute on chronic pain; post operative pain; SMS questionnaire

Outcome Measures

Primary Outcomes (1)

• Persistent pain

  The percentage of patients reporting pain equivalent to an NRS score \> 3 after 6 months

  after 6 months

Secondary Outcomes (23)

• Severe pain during the last 24 hours.

  Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.

• Severe pain at rest during the last 24 hours.

  Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.

• Use of analgesic medication in the past week due to pain (Paracetamol, Non-Steroidal Anti-Inflammatory Drug, opioid).

  Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.

• Pain's affect on daily activities

  Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.

• Pain's affect on engaging in strenuous physical activity.

  Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.

Other Outcomes (6)

• Recall of acute pain at 12 and 24 hours after CD

  Asked 12 months after CD.

• Percentage of patients experiencing pain with an NRS > 3

  1, 2, 3, and 12 months, as well as 1,5; 2; 2,5 and 3 years after cesarean delivery.

• Association between severe acute pain (NRS > 6) during the first 24 hours and the occurrence of persistent pain at 6 and 12 months after CD.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients having a cesarean section
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients, aged \> 18 years, who undergo planned cesarean delivery under spinal anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• \<18 years of age

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Patricia Duch, MD

  University Hospital of Copenhagen, Hillerød, Denmark

  PRINCIPAL INVESTIGATOR

• Helene Nedergaard, MD, Ph.D

  University Hospital of Southern Denmark, Kolding

  STUDY DIRECTOR

• Christoffer Jørgensen, Dr. Med.

  University Hospital of Copenhagen, Hillerød, Denmark

  STUDY DIRECTOR

• Kim Wildgaard, MD, Ph.d.

  University Hospital of Copenhagen, Herlev, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 8, 2024
• Study Start: September 1, 2023
• Primary Completion: June 10, 2025
• Study Completion: September 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)