Back to resultsTransversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus abdominis plane block
Rectus sheath block
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring Postoperative pain, Transversus abdominis plane block, Rectus sheath block, Cesarean delivery
Eligibility Criteria
Inclusion Criteria:
ASA I-II patients Patients undergo elective cesarean delivery Gestation period between 37-40 weeks
Exclusion Criteria:
obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control group
TAP group
RS group
Arm Description
Transversus abdominis plane block administered group
Rectus sheath block administered group
Outcomes
Primary Outcome Measures
Morphine consumption
Morphine consumption (mg) of patients with patient controlled device
NRS score
Numerating rating scale of patients
Secondary Outcome Measures
Full Information
NCT ID
NCT03811067
First Posted
January 18, 2019
Last Updated
July 22, 2019
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03811067
Brief Title
Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery
Official Title
Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean delivery, interaction between the mother and her newborn baby can be provided earlier. Many regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is to compare the postoperative analgesia effects of transversus abdominis plane block and rectus sheath block after elective cesarean delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Transversus abdominis plane block, Rectus sheath block, Cesarean delivery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Title
TAP group
Arm Type
Active Comparator
Arm Description
Transversus abdominis plane block administered group
Arm Title
RS group
Arm Type
Active Comparator
Arm Description
Rectus sheath block administered group
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
Transversus abdominis plane block will be performed bilaterally after the surgery.
Intervention Type
Procedure
Intervention Name(s)
Rectus sheath block
Intervention Description
Rectus sheath block will be performed bilaterally after the surgery.
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Morphine consumption (mg) of patients with patient controlled device
Time Frame
Postoperative 24th hour.
Title
NRS score
Description
Numerating rating scale of patients
Time Frame
Postoperative 24th hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II patients Patients undergo elective cesarean delivery Gestation period between 37-40 weeks
Exclusion Criteria:
obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadi Ufuk MD Yörükoğlu
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41350
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery
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