Back to resultsDouble Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lower segment cesarean section and double lock closure of rectus sheath
lower segment cesarean section and continuous non-locking closure of rectus sheath
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- first cesarean section
Exclusion Criteria:
- urgent cesarean section
- previous abdominal surgery
- previous cesarean section
- obstetric and medical complications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group a
group b
Arm Description
This arm will have lower segment cesarean section done with double locking technique for closure of Rectus Sheath.
This arm will have lower segment cesarean section done with continuous non-locking technique for closure of rectus sheath.
Outcomes
Primary Outcome Measures
postoperative pain evaluated by VAS
Secondary Outcome Measures
operative time
Full Information
NCT ID
NCT02679365
First Posted
February 7, 2016
Last Updated
July 30, 2017
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02679365
Brief Title
Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
5. Study Description
Brief Summary
In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique.
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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group a
Arm Type
Experimental
Arm Description
This arm will have lower segment cesarean section done with double locking technique for closure of Rectus Sheath.
Arm Title
group b
Arm Type
Active Comparator
Arm Description
This arm will have lower segment cesarean section done with continuous non-locking technique for closure of rectus sheath.
Intervention Type
Procedure
Intervention Name(s)
lower segment cesarean section and double lock closure of rectus sheath
Intervention Type
Procedure
Intervention Name(s)
lower segment cesarean section and continuous non-locking closure of rectus sheath
Primary Outcome Measure Information:
Title
postoperative pain evaluated by VAS
Time Frame
first week postoperative
Secondary Outcome Measure Information:
Title
operative time
Time Frame
intraoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
first cesarean section
Exclusion Criteria:
urgent cesarean section
previous abdominal surgery
previous cesarean section
obstetric and medical complications
12. IPD Sharing Statement
Learn more about this trial
Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain
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