Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

Chronic Pain Clinical Trial

Official title:

Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247852
• Other study ID #: 101
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: Nordsjaellands Hospital
• Contact: Patricia Duch, MD
• Phone: 0045 48292504
• Email: patricia.duch[@]regioh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2029
• Est. primary completion date: July 1, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recall of acute pain at 12 and 24 hours after CD	Exploratory	Asked 12 months after CD.
Other	Percentage of patients experiencing pain with an NRS > 3	Exploratory	1, 2, 3, and 12 months, as well as 1,5; 2; 2,5 and 3 years after cesarean delivery.
Other	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.	Exploratory	12 months
Other	Prevalence of chronic pain before pregnancy.	Exploratory	6 months
Other	Prevalence of chronic pain before pregnancy and its association with the development of persistent pain	Exploratory	1, 2, 3, and 12 months, as well as 1,5; 2; 2,5 and 3 years after cesarean delivery.
Other	6. Association between uterine exteriorization versus in situ repair in CD and the occurrence of persistent pain	Exploratory	1, 2, 3, and 12 months, as well as 1,5; 2; 2,5 and 3 years after cesarean delivery.
Primary	Persistent pain	The percentage of patients reporting pain equivalent to an NRS score > 3 after 6 months	after 6 months
Secondary	Severe pain during the last 24 hours.	NRS 0-10	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Severe pain at rest during the last 24 hours.	NRS 0-10	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Use of analgesic medication in the past week due to pain (Paracetamol, Non-Steroidal Anti-Inflammatory Drug, opioid).	Yes/No	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain's affect on daily activities	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain's affect on engaging in strenuous physical activity.	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.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain's affect on meeting the infant's needs.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain's affect on sleep.	1-4: Not at all, a little, to some extent, to a great extent.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain's affect on mood.	1-4: Not at all, a little, to some extent, to a great extent.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort when sitting down or standing up from a chair.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort when walking on stairs.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort when getting in or out of bed.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort when carrying the infant.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort when sitting up for less than 30 minutes.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort if sitting up for more than 30 minutes.	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.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort when moving around at home.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort if walking for more than 30 minutes.	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.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort when bending down.	1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain/discomfort during or after sexual intercourse.	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.	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pins and needles, tingling or stabbing sensations in or around the area of the surgery?	Yes/No	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Electric shock like sensation or jabbing feelings in the skin area in or around the area of the surgery?	Yes/No	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Heat or burning sensations in or around the area of the surgery?	Yes/No	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain caused by the lightest of touches in or around the area of the surgery?	Yes/No	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Secondary	Pain caused by cold temperatures in or around the area of surgery?	Yes/No	Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.