An interventional study of Rectus closure in Pain, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.
Procedure: Rectus closure
Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
Reapproximation of the rectus muscles with three-interrupted sutures
Post-operative Pain
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.
Time frame: 72-hour study period
Operative Times
Operative time of the cesarean delivery in minutes.
Time frame: From start to the end of the cesarean delivery, assessed up to two hours.
| Milestone | Rectus Muscle Closure | Rectus Muscle Non-closure |
|---|---|---|
| Started | 35 | 28 |
| Completed | 35 | 28 |
| Not completed | 0 | 0 |
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.
| Scores on a scale | Rectus Muscle Closure | Rectus Muscle Non-closure |
|---|---|---|
| Post-operative Pain | 15 ± 100 | -31 ± 78 |
Operative time of the cesarean delivery in minutes.
| minutes | Rectus Muscle Closure | Rectus Muscle Non-closure |
|---|---|---|
| Operative Times | 63 ± 15 | 65 ± 15 |
Collected over 6 weeks after the delivery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rectus Muscle Closure | — | 0/35 (0%) | 0/35 (0%) |
| Rectus Muscle Non-closure | — | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Rectus Muscle Closure | Rectus Muscle Non-closure | Total |
|---|---|---|---|
| Mean | 31 ± 7 | 33 ± 7 | 32 ± 7 |
| Sex: Female, Male(Participants) | Rectus Muscle Closure | Rectus Muscle Non-closure | Total |
|---|---|---|---|
| Female | 35 | 28 | 63 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Rectus Muscle Closure | Rectus Muscle Non-closure | Total |
|---|---|---|---|
| United States | 35 | 28 | 63 |
| Gestational age at delivery(weeks) | Rectus Muscle Closure | Rectus Muscle Non-closure | Total |
|---|---|---|---|
| Median | 39 (37 to 39) | 38 (37 to 39) | 39 (37 to 39) |
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