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Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block

Sponsor
Istanbul Saglik Bilimleri University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05625009
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
3.9
Anticipated Duration (Months)
25.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)
  • Procedure: Procedure/Surgery: Erector Spinae Plane Block (ESPB)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes 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
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 24, 2022
Anticipated Primary Completion Date :
Jan 24, 2023
Anticipated Study Completion Date :
Mar 24, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Transversus Abdominis Plane Block (TAPB)

patients received TAPB postoperatively

Procedure: Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)
Patients received TAPB postoperatively
Experimental: Experimental: Erector Spinae Plane Block (ESPB)

patients received ESPB postoperatively

Procedure: Procedure/Surgery: Erector Spinae Plane Block (ESPB)
Patients received ESPB postoperatively

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients needed for rescue analgesic agent (diclofenac) [24 hours]

Secondary Outcome Measures

  1. Percentage of patients needed for rescue analgesic agent (opioid) [24 hours]

  2. the dose of the opioid used [24 hours]

  3. Percentage of patients experienced chronic pain [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Basaksehir Cam and Sakura City Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Saglik Bilimleri University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taner Abdullah, Principal Investigator, Istanbul Saglik Bilimleri University
ClinicalTrials.gov Identifier:
NCT05625009
Other Study ID Numbers:
  • 2021.10.227
First Posted:
Nov 22, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Nov 30, 2022