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

May 3, 2023 updated by: Taner Abdullah, Istanbul Saglik Bilimleri University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Basaksehir Cam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients needed for rescue analgesic agent (diclofenac)
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients needed for rescue analgesic agent (opioid)
Time Frame: 24 hours
24 hours
the dose of the opioid used
Time Frame: 24 hours
24 hours
Percentage of patients experienced chronic pain
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Saglik Bilimleri University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2022

Primary Completion (Actual)

January 24, 2023

Study Completion (Actual)

April 2, 2023

Study Registration Dates

First Submitted

November 11, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 22, 2022

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021.10.227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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