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

NCT ID: NCT04108975

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Rectus muscle reapproximation group

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

Group Type ACTIVE_COMPARATOR

Rectus muscle reapproximation during CS

Intervention Type PROCEDURE

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

Rectus muscle non reapproximation group

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

Group Type ACTIVE_COMPARATOR

Rectus muscle non reapproximation during CS

Intervention Type PROCEDURE

During CS rectus muscle non reapproximation will be done.

Interventions

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Rectus muscle reapproximation during CS

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

Intervention Type PROCEDURE

Rectus muscle non reapproximation during CS

During CS rectus muscle non reapproximation will be done.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelraheem Ali

Obstetrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Aboalfadl, Professor

Role: STUDY_DIRECTOR

Assiut University

Diaa Abdelaal, Professor

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Abdelraheem Ahmed, Dr

Role: CONTACT

Phone: +201090435363

Email: [email protected]

Other Identifiers

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Rectus muscle reapproximation

Identifier Type: -

Identifier Source: org_study_id