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

NCT04108975 | Unknown

• 1 other identifier: Rectus muscle reapproximation
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rectus muscle reapproximation group

ACTIVE COMPARATOR

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

Procedure: Rectus muscle reapproximation during CS

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

Procedure: Rectus muscle non reapproximation during CS

Interventions

Rectus muscle reapproximation during CS PROCEDURE

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

Rectus muscle reapproximation group

Rectus muscle non reapproximation during CS PROCEDURE

During CS rectus muscle non reapproximation will be done.

Rectus muscle non reapproximation group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ahmed Aboalfadl, Professor

  Assiut University

  STUDY DIRECTOR

• Diaa Abdelaal, Professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Abdelraheem Ahmed, Dr

CONTACT

+201090435363; abdelrahim_muhammed2017@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share