Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505362
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2007-07-19
Brief Title:
Pain Study of Rectus Muscle Closure at Cesarean Delivery
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Rectus Muscle Closure vs Non-Closure at Primary Cesarean Delivery and Post-Operative Pain
Status:
COMPLETED
Status Verified Date:
2017-10
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:
Suture reapproximation of the rectus muscles at primary cesarean delivery is a common practice about which there are no data Some Obstetricians believe that suture reapproximation of the rectus muscles increases post-operative pain and it may decrease adhesions yet there are no published data to support or refute these claims The purpose of this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and post-operative pain We also plan to assess the impact of rectus muscle closure on adhesions as seen at repeat cesarean delivery
Detailed Description:
There are more than 1 million cesarean deliveries performed annually in the United States at a rate of 302 of all deliveries Data are limited regarding optimal surgical closure techniques to minimize adhesions at cesarean Adhesions are implicated in pelvic pain infertility difficult repeat surgery and bowel obstruction Practice techniques regarding rectus muscle reapproximation vary widely and there are no data regarding the impact of this step on pain and some data suggesting a reduction in significant adhesions Given the frequency of cesarean deliveries small changes in surgical technique may yield significant benefits
We hope to learn 1 whether suture reapproximation of the rectus muscles increases pain and 2 the degree to which suture reapproximation of the rectus muscles alters adhesions when studied in a prospective randomized trial
All patients undergoing primary cesarean delivery at Lucile Packard Childrens Hospital LPCH will be offered the study Once consented patients will be randomized to one of two standardized closure techniques at cesarean two-layer uterine closure peritoneal closure fascial and skin closure and either reapproximation of the rectus muscles with three-interrupted sutures or non-closure Intra-operative and post-operative pain management will be standardized Subjects will undergo pain assessments while in-house on post-operative days 1 and 3 and at the standard post-partum clinic visit after 6 weeks These assessments will require less than 5 minutes of the patients time Patients will be shown a pain chart and will be asked to rate their pain on a scale of 0 to 10 at rest They will then stand up and rate their pain again Pain medication usage will also be assessed
The surgeons will know the groups to which the patients are randomized The patients and those collecting data on pain scores will not
Primary Endpoint combined opioid use and movement pain score Silverman Integrated Assessment-SIA 72 post-operative hours
Secondary Endpoint surgical complications maternal satisfaction with analgesia
We hope to learn 1 whether suture reapproximation of the rectus muscles increases pain and 2 the degree to which suture reapproximation of the rectus muscles alters adhesions when studied in a prospective randomized trial
All patients undergoing primary cesarean delivery at Lucile Packard Childrens Hospital LPCH will be offered the study Once consented patients will be randomized to one of two standardized closure techniques at cesarean two-layer uterine closure peritoneal closure fascial and skin closure and either reapproximation of the rectus muscles with three-interrupted sutures or non-closure Intra-operative and post-operative pain management will be standardized Subjects will undergo pain assessments while in-house on post-operative days 1 and 3 and at the standard post-partum clinic visit after 6 weeks These assessments will require less than 5 minutes of the patients time Patients will be shown a pain chart and will be asked to rate their pain on a scale of 0 to 10 at rest They will then stand up and rate their pain again Pain medication usage will also be assessed
The surgeons will know the groups to which the patients are randomized The patients and those collecting data on pain scores will not
Primary Endpoint combined opioid use and movement pain score Silverman Integrated Assessment-SIA 72 post-operative hours
Secondary Endpoint surgical complications maternal satisfaction with analgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None