Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

Active, not recruiting

• Conditions: Cesarean Section Complications; SMS; Cesarean Delivery; Chronic Pain; Cesarean Section; Persistent Pain; Questionnaire

• Registration Number: NCT06247852
• Lead Sponsor: Nordsjaellands Hospital

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.

Detailed Description

The Study Protocol is attached in full-text (Study Documents).

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-06-10
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	NRS 0-10
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.	NRS 0-10
Pain/discomfort when sitting down or standing up from a chair.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Pain/discomfort when walking on stairs.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Pain/discomfort when carrying the infant.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Pain/discomfort when sitting up for less than 30 minutes.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Pain's affect on mood.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-4: Not at all, a little, to some extent, to a great extent.
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.	Yes/No
Pain's affect on sleep.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-4: Not at all, a little, to some extent, to a great extent.
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.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
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.	1-6: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried.
Pain's affect on meeting the infant's needs.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Pain/discomfort when getting in or out of bed.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Pain/discomfort when moving around at home.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Heat or burning sensations in or around the area of the surgery?	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	Yes/No
Pain/discomfort if sitting up for more than 30 minutes.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-6: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried.
Pain/discomfort if walking for more than 30 minutes.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-6: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried.
Pain/discomfort when bending down.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Pain/discomfort during or after sexual intercourse.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	1-7: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried, I prefer not to answer.
Pins and needles, tingling or stabbing sensations in or around the area of the surgery?	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	Yes/No
Electric shock like sensation or jabbing feelings in the skin area in or around the area of the surgery?	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	Yes/No
Pain caused by cold temperatures in or around the area of surgery?	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	Yes/No
Pain caused by the lightest of touches in or around the area of the surgery?	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.	Yes/No

Trial Locations

Locations (1)

Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød; 🇩🇰 Hillerød, Denmark