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Completed

NCT Number: NCT06247852

Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

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.

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Key information

Conditions

Cesarean Section Complications Cesarean Delivery Cesarean Section Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Pain Postoperative Complications Questionnaire SMS Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød

Hillerød, 3400, Denmark

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Persistent pain

    Time frame: after 6 months

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

Secondary outcomes

  1. Severe pain during the last 24 hours.

    Time frame: 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

  2. Severe pain at rest during the last 24 hours.

    Time frame: 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

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

    Time frame: 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

  4. Pain's affect on daily activities

    Time frame: 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.

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

    Time frame: 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.

  6. Pain's affect on meeting the infant's needs.

    Time frame: 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.

  7. Pain's affect on sleep.

    Time frame: 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.

  8. Pain's affect on mood.

    Time frame: 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.

  9. Pain/discomfort when sitting down or standing up from a chair.

    Time frame: 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.

  10. Pain/discomfort when walking on stairs.

    Time frame: 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.

  11. Pain/discomfort when getting in or out of bed.

    Time frame: 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.

  12. Pain/discomfort when carrying the infant.

    Time frame: 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.

  13. Pain/discomfort when sitting up for less than 30 minutes.

    Time frame: 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.

  14. Pain/discomfort if sitting up for more than 30 minutes.

    Time frame: 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.

  15. Pain/discomfort when moving around at home.

    Time frame: 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.

  16. Pain/discomfort if walking for more than 30 minutes.

    Time frame: 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.

  17. Pain/discomfort when bending down.

    Time frame: 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.

  18. Pain/discomfort during or after sexual intercourse.

    Time frame: 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.

  19. Pins and needles, tingling or stabbing sensations in or around the area of the surgery?

    Time frame: 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

  20. Electric shock like sensation or jabbing feelings in the skin area in or around the area of the surgery?

    Time frame: 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

  21. Heat or burning sensations in or around the area of the surgery?

    Time frame: 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

  22. Pain caused by the lightest of touches in or around the area of the surgery?

    Time frame: 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

  23. Pain caused by cold temperatures in or around the area of surgery?

    Time frame: 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

Other outcomes

  1. Recall of acute pain at 12 and 24 hours after CD

    Time frame: Asked 12 months after CD.

    Exploratory

  2. Percentage of patients experiencing pain with an NRS > 3

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

    Exploratory

  3. 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.

    Time frame: 12 months

    Exploratory

  4. Prevalence of chronic pain before pregnancy.

    Time frame: 6 months

    Exploratory

  5. Prevalence of chronic pain before pregnancy and its association with the development of persistent pain

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

    Exploratory

  6. 6. Association between uterine exteriorization versus in situ repair in CD and the occurrence of persistent pain

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

    Exploratory

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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