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Clinical Trials/NCT04108975
NCT04108975UnknownNot Applicable

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

Assiut University0 sites156 target enrollmentStarted: October 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
156
Primary Endpoint
Postoperative pain: 4 point verbal rating scale (VRS)

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
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.

Arms & Interventions

Rectus muscle reapproximation group

Active Comparator

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

Intervention: Rectus muscle reapproximation during CS (Procedure)

Rectus muscle non reapproximation group

Active Comparator

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

Intervention: Rectus muscle non reapproximation during CS (Procedure)

Outcomes

Primary Outcomes

Postoperative pain: 4 point verbal rating scale (VRS)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdelraheem Ali

Obstetrician

Assiut University

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