Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
Primary Purpose
Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)
Procedure/Surgery: Erector Spinae Plane Block (ESPB)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria: 18 - 45 years ASA2 Undergoing cesarean section under spinal anesthesia Exclusion Criteria: History of chronic pain Body mass index > 35 Urgent/emergent surgeries Major bleeding Any additional surgical procedure Contraindication for any drugs used in the protocol The presence of any instrumentation in the procedure sites
Sites / Locations
- Istanbul Basaksehir Cam and Sakura City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: Transversus Abdominis Plane Block (TAPB)
Experimental: Erector Spinae Plane Block (ESPB)
Arm Description
patients received TAPB postoperatively
patients received ESPB postoperatively
Outcomes
Primary Outcome Measures
Percentage of patients needed for rescue analgesic agent (diclofenac)
Secondary Outcome Measures
Percentage of patients needed for rescue analgesic agent (opioid)
the dose of the opioid used
Percentage of patients experienced chronic pain
Full Information
NCT ID
NCT05625009
First Posted
November 11, 2022
Last Updated
May 3, 2023
Sponsor
Istanbul Saglik Bilimleri University
1. Study Identification
Unique Protocol Identification Number
NCT05625009
Brief Title
Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
Official Title
Comparison of Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block in the Management of Postoperative Analgesia in Patients Who Had Cesarean Section Under Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
April 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Saglik Bilimleri 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
Transversus Abdominis Plane Block (TAPB) is frequently used for the management of postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane Block (ESPB) has been defined and used in several clinical scenarios. However, data regarding the ESPB use in the aforementioned patient group is limited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block, Transversus Abdominis Plane Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The investigators who assessed pain scores postoperatively are blinded to the study groups Care providers on the yard are blinded to the study groups Outcome assessors are blinded to the study groups
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Transversus Abdominis Plane Block (TAPB)
Arm Type
Experimental
Arm Description
patients received TAPB postoperatively
Arm Title
Experimental: Erector Spinae Plane Block (ESPB)
Arm Type
Experimental
Arm Description
patients received ESPB postoperatively
Intervention Type
Procedure
Intervention Name(s)
Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)
Intervention Description
Patients received TAPB postoperatively
Intervention Type
Procedure
Intervention Name(s)
Procedure/Surgery: Erector Spinae Plane Block (ESPB)
Intervention Description
Patients received ESPB postoperatively
Primary Outcome Measure Information:
Title
Percentage of patients needed for rescue analgesic agent (diclofenac)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Percentage of patients needed for rescue analgesic agent (opioid)
Time Frame
24 hours
Title
the dose of the opioid used
Time Frame
24 hours
Title
Percentage of patients experienced chronic pain
Time Frame
2 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 - 45 years
ASA2
Undergoing cesarean section under spinal anesthesia
Exclusion Criteria:
History of chronic pain
Body mass index > 35
Urgent/emergent surgeries
Major bleeding
Any additional surgical procedure
Contraindication for any drugs used in the protocol
The presence of any instrumentation in the procedure sites
Facility Information:
Facility Name
Istanbul Basaksehir Cam and Sakura City Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
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