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).
Study Type
OBSERVATIONAL
Enrollment
477
Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
Hillerød, Denmark
Persistent pain
The percentage of patients reporting pain equivalent to an NRS score \> 3 after 6 months
Time frame: after 6 months
Severe pain during the last 24 hours.
NRS 0-10
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.
Severe pain at rest during the last 24 hours.
NRS 0-10
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.
Use of analgesic medication in the past week due to pain (Paracetamol, Non-Steroidal Anti-Inflammatory Drug, opioid).
Yes/No
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.
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.
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.
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.
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.
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.
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.
Pain's affect on sleep.
1-4: Not at all, a little, to some extent, to a great extent.
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.
Pain's affect on mood.
1-4: Not at all, a little, to some extent, to a great extent.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pain/discomfort when bending down.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
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.
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.
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.
Pins and needles, tingling or stabbing sensations in or around the area of the surgery?
Yes/No
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.
Electric shock like sensation or jabbing feelings in the skin area in or around the area of the surgery?
Yes/No
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.
Heat or burning sensations in or around the area of the surgery?
Yes/No
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.
Pain caused by the lightest of touches in or around the area of the surgery?
Yes/No
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.
Pain caused by cold temperatures in or around the area of surgery?
Yes/No
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.
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