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Pain Study of Rectus Muscle Closure at Cesarean Delivery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deirdre Judith Lyell, Stanford University
ClinicalTrials.gov Identifier:
NCT00505362
First received: July 19, 2007
Last updated: February 6, 2017
Last verified: February 2017
July 19, 2007
February 6, 2017
June 2006
August 2014   (Final data collection date for primary outcome measure)
Post-operative Pain [ Time Frame: 72-hour study period ]
Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient's total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.
Post-operative Pain [ Time Frame: Six weeks ]
Complete list of historical versions of study NCT00505362 on ClinicalTrials.gov Archive Site
Operative Times [ Time Frame: From start to the end of the cesarean delivery, assessed up to two hours. ]
Operative time of the cesarean delivery in minutes.
Post-operative adhesions [ Time Frame: Years: at time of repeat cesarean ]
Not Provided
Not Provided
 
Pain Study of Rectus Muscle Closure at Cesarean Delivery
Rectus Muscle Closure vs. Non-Closure at Primary Cesarean Delivery and Post-Operative Pain
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.

There are more than 1 million cesarean deliveries performed annually in the United States, at a rate of 30.2% 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 patient's 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Pain
Procedure: Rectus closure
Reapproximation of the rectus muscles with three-interrupted sutures
  • Active Comparator: Rectus muscle closure
    Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.
    Intervention: Procedure: Rectus closure
  • No Intervention: Rectus muscle non-closure
    Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
May 2017
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

37 weeks gestation Primary cesarean American Society of Anesthesiologists (ASA) class 1 or class 2

Exclusion Criteria:

Chronic analgesia use Vertical skin incision at cesarean Opioid or Non-steroidal anti-inflammatory drugs (NSAID) allergy BMI >40 Labor

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00505362
6107
No
Not Provided
Plan to Share IPD: No
Deirdre Judith Lyell, Stanford University
Stanford University
Not Provided
Principal Investigator: Deirdre Judith Lyell Stanford University
Stanford University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP