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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rectus muscle reapproximation during CS
Rectus muscle non reapproximation during CS
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Rectus muscle reapproximation group

    Rectus muscle non reapproximation group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2019
    Last Updated
    September 27, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04108975
    Brief Title
    Assessment of the Effect of Rectus Muscle Reapproximation Versus Non Reapproximation During CS on Postoperative Pain
    Official Title
    Assessment of the Effect of Rectus Muscle Reapproximation Versus Non Reapproximation During CS on Postoperative Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    156 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rectus muscle reapproximation group
    Arm Type
    Active Comparator
    Arm Description
    Rectus muscle reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures
    Arm Title
    Rectus muscle non reapproximation group
    Arm Type
    Active Comparator
    Arm Description
    No rectus muscle reapproximation will be done based on the fact that rectus muscle can regain its position
    Intervention Type
    Procedure
    Intervention Name(s)
    Rectus muscle reapproximation during CS
    Intervention Description
    Reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures.
    Intervention Type
    Procedure
    Intervention Name(s)
    Rectus muscle non reapproximation during CS
    Intervention Description
    During CS rectus muscle non reapproximation will be done.
    Primary Outcome Measure Information:
    Title
    Postoperative pain: 4 point verbal rating scale (VRS)
    Description
    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.
    Time Frame
    1 week after operation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelraheem Ahmed, Dr
    Phone
    +201090435363
    Email
    abdelrahim_muhammed2017@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Aboalfadl, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Diaa Abdelaal, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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