Back to resultsTab Block and Patient Controlled Analgesia in CS
Primary Purpose
Analgesia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tab block
PCA
women who will not receive tab block or PCA
Sponsored by
About this trial
This is an interventional supportive care trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- women coming for an elective CS
Exclusion Criteria:
- women who has a n emergency CS or complicated normal deivery needs urgent CS
Sites / Locations
- Aljazeera( Al Gazeera) hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
giving tab block
giving PCA
Patients who will not receive PCA or tab block
Arm Description
giving patients tab block
Giving PCA to patients
No tab block or PCA
Outcomes
Primary Outcome Measures
The number of women who will feel less pain post CS
the degree of pain that will be felt post CS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04405336
Brief Title
Tab Block and Patient Controlled Analgesia in CS
Official Title
Effect of Tab Block and Patient Controlled Analgesia in Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
cesarean section rate become increasing nowadays
Detailed Description
indication of cesarean section are different from case to case and the use of pain controlling agents is very important to relieve post operative pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
giving tab block
Arm Type
Active Comparator
Arm Description
giving patients tab block
Arm Title
giving PCA
Arm Type
Active Comparator
Arm Description
Giving PCA to patients
Arm Title
Patients who will not receive PCA or tab block
Arm Type
No Intervention
Arm Description
No tab block or PCA
Intervention Type
Drug
Intervention Name(s)
tab block
Intervention Description
injection of tab block to women who are doing cs
Intervention Type
Drug
Intervention Name(s)
PCA
Intervention Description
giving women PCA
Intervention Type
Drug
Intervention Name(s)
women who will not receive tab block or PCA
Intervention Description
no tab block or PCA will be given
Primary Outcome Measure Information:
Title
The number of women who will feel less pain post CS
Description
the degree of pain that will be felt post CS
Time Frame
2 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women undergoing CS
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women coming for an elective CS
Exclusion Criteria:
women who has a n emergency CS or complicated normal deivery needs urgent CS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
Algezeera hospitaland National Research Centre ,Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Aljazeera( Al Gazeera) hospital
City
Giza
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Tab Block and Patient Controlled Analgesia in CS
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