Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
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
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
November 22, 2022
CompletedStudy Start
First participant enrolled
November 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2023
CompletedMay 6, 2023
May 1, 2023
2 months
November 11, 2022
May 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients needed for rescue analgesic agent (diclofenac)
24 hours
Secondary Outcomes (3)
Percentage of patients needed for rescue analgesic agent (opioid)
24 hours
the dose of the opioid used
24 hours
Percentage of patients experienced chronic pain
2 months
Study Arms (2)
Experimental: Transversus Abdominis Plane Block (TAPB)
EXPERIMENTALpatients received TAPB postoperatively
Experimental: Erector Spinae Plane Block (ESPB)
EXPERIMENTALpatients received ESPB postoperatively
Interventions
Patients received TAPB postoperatively
Patients received ESPB postoperatively
Eligibility Criteria
You may qualify if:
- years
- ASA2
- Undergoing cesarean section under spinal anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Basaksehir Cam and Sakura City Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 11, 2022
First Posted
November 22, 2022
Study Start
November 24, 2022
Primary Completion
January 24, 2023
Study Completion
April 2, 2023
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share