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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.
The Study Protocol is attached in full-text (Study Documents).
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| Measure | Description | Time Frame |
|---|---|---|
| Persistent pain | The percentage of patients reporting pain equivalent to an NRS score > 3 after 6 months | after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Severe pain at rest during the last 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Recall of acute pain at 12 and 24 hours after CD | Exploratory | Asked 12 months after CD. |
| Percentage of patients experiencing pain with an NRS > 3 | Exploratory |
Inclusion Criteria:
Exclusion Criteria:
• <18 years of age
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Patients having a cesarean section
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Patients, aged > 18 years, who undergo planned cesarean delivery under spinal anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød | Hillerød | 3400 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2024 | Jan 30, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. | Exploratory | 12 months |
| Prevalence of chronic pain before pregnancy. | Exploratory | 6 months |
| 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. |
| 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. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |