Assessment of the Effect of Rectus Muscle Reapproximation Versus Non Reapproximation During CS on Postoperative Pain

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04108975

Collaborator

(none)

156

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Rectus muscle reapproximation during CS Procedure: Rectus muscle non reapproximation during CS	N/A

Detailed Description

In recent years, Cesarean deliveries have increased dramatically worldwide. In Egypt, 52% of women give birth by Cesarean Section according to the 2014 Demographic and Health survey. Despite the rising incidence of Cesarean section, controversy about the optimal surgical method of Cesarean section still remains. Obstetricians use a variety of surgical techniques to reduce post-operative adhesions after Cesarean section, such as parietal peritoneal closure and rectal muscle approximation. They believe that adhesions may result from exposure of an opened intraperitoneal cavity to the subfascial space which can be prevented by approximating the rectus muscle or closing the parietal peritoneum. In addition, rectus muscle approximation may be considered to reduce the risk of persistent rectus muscle diastasis. However, different studies showed a controversy and inconsistency in the practice of rectus muscle re-approximation among surgeons. Some obstetricians agree that the rectus muscles can regain their right anatomic position by themselves and that suturing them together does not add any benefit. Even though, one of their main concern against rectus muscle approximation is its potential association with increased post operative pain, hence the importance of this prospective randomized controlled study. The aim of the investigator's study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Assessment of the Effect of Rectus Muscle Reapproximation Versus Non Reapproximation During CS on Postoperative Pain

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rectus muscle reapproximation group Rectus muscle reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures	Procedure: Rectus muscle reapproximation during CS Reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures.
Active Comparator: Rectus muscle non reapproximation group No rectus muscle reapproximation will be done based on the fact that rectus muscle can regain its position	Procedure: Rectus muscle non reapproximation during CS During CS rectus muscle non reapproximation will be done.

Arm

Intervention/Treatment

Active Comparator: Rectus muscle reapproximation group

Rectus muscle reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures

Procedure: Rectus muscle reapproximation during CS

Reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures.

Active Comparator: Rectus muscle non reapproximation group

No rectus muscle reapproximation will be done based on the fact that rectus muscle can regain its position

Procedure: Rectus muscle non reapproximation during CS

During CS rectus muscle non reapproximation will be done.

Outcome Measures

Primary Outcome Measures

Postoperative pain: 4 point verbal rating scale (VRS) [1 week after operation]
Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

• Primigravida
Single pregnancy
Term at >37 weeks
Maternal age between 18 and 35 yrs
Spinal anaesthesia.
No other medical diseases.

Exclusion Criteria:

• prior laparotomy
vertical skin incision
chronic analgesia use
allergy to opioid or nonsteroidal anti-inflammatory drugs
body mass index more than or equal to 40.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Ahmed Aboalfadl, Professor, Assiut University
Study Chair: Diaa Abdelaal, Professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdelraheem Ali, Obstetrician, Assiut University

ClinicalTrials.gov Identifier:

NCT04108975

Other Study ID Numbers:

Rectus muscle reapproximation

First Posted:

Sep 30, 2019

Last Update Posted:

Sep 30, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Sep 30, 2019