Clinical trial NCT06247852: Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Official title: Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, aged \> 18 years, who undergo planned cesarean delivery under spinal anesthesia.

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).

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

Primary outcomes:
measure: Persistent pain
timeFrame: after 6 months
Secondary outcomes:
measure: Severe pain during the last 24 hours.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Severe pain at rest during the last 24 hours.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Use of analgesic medication in the past week due to pain (Paracetamol, Non-Steroidal Anti-Inflammatory Drug, opioid).
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain's affect on daily activities
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain's affect on engaging in strenuous physical activity.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain's affect on meeting the infant's needs.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain's affect on sleep.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain's affect on mood.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort when sitting down or standing up from a chair.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort when walking on stairs.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort when getting in or out of bed.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort when carrying the infant.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort when sitting up for less than 30 minutes.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort if sitting up for more than 30 minutes.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort when moving around at home.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort if walking for more than 30 minutes.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort when bending down.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain/discomfort during or after sexual intercourse.
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pins and needles, tingling or stabbing sensations in or around the area of the surgery?
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Electric shock like sensation or jabbing feelings in the skin area in or around the area of the surgery?
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Heat or burning sensations in or around the area of the surgery?
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain caused by the lightest of touches in or around the area of the surgery?
timeFrame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
measure: Pain caused by cold temperatures in or around the area of surgery?
timeFrame: 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:
measure: Recall of acute pain at 12 and 24 hours after CD
timeFrame: Asked 12 months after CD.
measure: Percentage of patients experiencing pain with an NRS > 3
timeFrame: 1, 2, 3, and 12 months, as well as 1,5; 2; 2,5 and 3 years after cesarean delivery.
measure: 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.
timeFrame: 12 months
measure: Prevalence of chronic pain before pregnancy.
timeFrame: 6 months
measure: Prevalence of chronic pain before pregnancy and its association with the development of persistent pain
timeFrame: 1, 2, 3, and 12 months, as well as 1,5; 2; 2,5 and 3 years after cesarean delivery.
measure: 6. Association between uterine exteriorization versus in situ repair in CD and the occurrence of persistent pain
timeFrame: 1, 2, 3, and 12 months, as well as 1,5; 2; 2,5 and 3 years after cesarean delivery.
Locations:
city: Hillerød
country: Denmark
facility: Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
Study officials:
affiliation: University Hospital of Copenhagen, Hillerød, Denmark
name: Patricia Duch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Southern Denmark, Kolding
name: Helene Nedergaard, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: University Hospital of Copenhagen, Hillerød, Denmark
name: Christoffer Jørgensen, Dr. Med.
role: STUDY_DIRECTOR
affiliation: University Hospital of Copenhagen, Herlev, Denmark
name: Kim Wildgaard, MD, Ph.d.
role: STUDY_CHAIR
References: