Pain Study of Rectus Muscle Closure at Cesarean Delivery

NCT00505362 | Completed Results

• 1 other identifier: 6107
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  72-hour study period

Secondary Outcomes (1)

• Operative Times

  From start to the end of the cesarean delivery, assessed up to two hours.

Study Arms (2)

Rectus muscle closure

ACTIVE COMPARATOR

Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.

Procedure: Rectus closure

Rectus muscle non-closure

NO INTERVENTION

Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.

Interventions

Rectus closure PROCEDURE

Reapproximation of the rectus muscles with three-interrupted sutures

Rectus muscle closure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anna Girsen, Manager of Research Operations
• Organization: Stanford University

agirsen@stanford.edu

6507250499

Study Officials

• Deirdre Judith Lyell

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 23, 2007
• Study Start: June 1, 2006
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2017
• Last Updated: November 6, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)