Pain Study of Rectus Muscle Closure at Cesarean Delivery
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/-0001 |
Start Date: | June 2006 |
End Date: | June 2015 |
Contact: | Deirdre Lyell, MD |
Email: | dlyell@stanford.edu |
Phone: | (650) 736-1191 |
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 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.
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
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