Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247852
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-08
Brief Title:
Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Denmark around 12700 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 ClinicalTrialsgov 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
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 ClinicalTrialsgov 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None