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Pain Study of Rectus Muscle Closure at Cesarean Delivery
This study is currently recruiting participants.
Verified by Stanford University, July 2007
First Received: July 19, 2007   Last Updated: July 20, 2007   History of Changes
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00505362
  Purpose

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.


Condition Intervention Phase
Pain
Complications
Adhesions
Procedure: Suture reapproximation of the rectus muscles
Phase II
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Rectus Muscle Closure vs. Non-Closure at Primary Cesarean Delivery and Post-Operative Pain

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Post-operative pain [ Time Frame: Six weeks ]

Secondary Outcome Measures:
  • Post-operative adhesions [ Time Frame: Years: at time of repeat cesarean ]

Estimated Enrollment: 112
Study Start Date: June 2006
Estimated Study Completion Date: December 2009
Detailed Description:

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 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.

For patients who undergo repeat cesarean delivery, their surgeons will be asked to fill out a validated adhesion assessment form following surgery. We will not dictate the method of surgical technique at repeat cesarean, but will simply ask surgeons to describe the adhesions. At the time of consent, the patient will be asked to contact the study coordinator in the future should they undergo cesarean. In addition, the study coordinators will contact patients one-year after enrollment to inquire about plans for future pregnancies.

The surgeons will know the groups to which the patients are randomized. The patients and those collecting data on pain scores will not.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 37 weeks gestation
  • Primary cesarean
  • ASA class 1 or class 2

Exclusion Criteria:

  • Chronic analgesia use
  • Vertical skin incision at cesarean
  • Opioid or NSAID allergy
  • BMI >40
  • Labor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505362

Contacts
Contact: Deirdre J Lyell, MD 650-736-1191 dlyell@stanford.edu
Contact: Jacqueline Laskey, BA 650-725-8623 jlaskey@lpch.org

Locations
United States, California
Lucile Packard Children's Hospital Recruiting
Stanford, California, United States, 94305
Principal Investigator: Deirdre J Lyell, MD            
Sub-Investigator: Brendan Carvalho, MD            
Sub-Investigator: Renata Urban, MD            
Sub-Investigator: Amy Wong, MD            
Sub-Investigator: Betsy Kogut, RN            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Deirdre J Lyell, MD Lucile Packard Children's Hospital at Stanford University
  More Information

No publications provided

Study ID Numbers: 6107
Study First Received: July 19, 2007
Last Updated: July 20, 2007
ClinicalTrials.gov Identifier: NCT00505362     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Cesarean delivery
Pain
Rectus muscle
Adhesions

Study placed in the following topic categories:
Adhesions
Pain
Pain, Postoperative

Additional relevant MeSH terms:
Pathologic Processes
Adhesions

ClinicalTrials.gov processed this record on September 11, 2009