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
About this trial
This is an interventional prevention trial for Postoperative Pain
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.
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
NCT ID
NCT04108975
First Posted
September 26, 2019
Last Updated
September 27, 2019
Sponsor
Assiut University
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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