Pain Study of Rectus Muscle Closure at Cesarean Delivery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00505362
First received: July 19, 2007
Last updated: August 9, 2013
Last verified: August 2013
  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
Procedure: Rectus closure vs. non-closure
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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: 24, 48 and 27 hours and 2 weeks post partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative adhesions [ Time Frame: subsequent pregnancy c/section ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: June 2006
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rectus muscle closure Procedure: Rectus closure vs. non-closure
Closure of the Rectus muscle vs. non-closure of the rectus muscle at cesarean section.
Active Comparator: Rectus muscle non-closure Procedure: Rectus closure vs. non-closure
Closure of the Rectus muscle vs. non-closure of the rectus muscle at cesarean section.

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 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.

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:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505362

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Deirdre Judith Lyell Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00505362     History of Changes
Other Study ID Numbers: 6107
Study First Received: July 19, 2007
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014