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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04108975
• Other study ID #: Rectus muscle reapproximation
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Abdelraheem Ahmed, Dr
• Phone: +201090435363
• Email: abdelrahim_muhammed2017[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Rectus muscle reapproximation during CS
Reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures.
• Rectus muscle non reapproximation during CS
During CS rectus muscle non reapproximation will be done.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain: 4 point verbal rating scale (VRS)	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.	1 week after operation