Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control

February 27, 2024 updated by: Warda Demerdash Khalifa Ali, Al-Azhar University

Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Pain Control After Cesarean Section in Obese and Morbidly Obese Women

The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. The present study will include ASA I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications. This study defines obesity as body mass index (BMI) ≥ 30 kg/m2 while morbid obesity is defined as BMI ≥ 40 kg/m2 assessed in the last pre-pregnancy visit (Sagi-Dain et al., 2021). The study will include normal weight women (n=86), obese women (n=86) and morbidly obese women (n=86).

Study Type

Interventional

Enrollment (Estimated)

68

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 Contact

Study Locations

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I-II women scheduled for elective CS under intrathecal anesthesia.

Exclusion Criteria:

  • had local infection, bleeding disorder or known allergy to any of the study medications

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Obese Spinae Plane Block
Spinae Plane Block for pain control
Procedure: Ultrasound-guided pain block
Ultrasound-guided pain block after cesarean section
Device: Ultrasound Machine
Ultrasound machine used to guide the nerve block.
Active Comparator: Obese Transversus Abdominis Plane Block
Transversus Abdominis Plane Block for pain control.
Procedure: Ultrasound-guided pain block
Ultrasound-guided pain block after cesarean section
Device: Ultrasound Machine
Ultrasound machine used to guide the nerve block.
Active Comparator: Morbidly Obese Spinae Plane Block
Spinae Plane Block for pain control
Procedure: Ultrasound-guided pain block
Ultrasound-guided pain block after cesarean section
Device: Ultrasound Machine
Ultrasound machine used to guide the nerve block.
Active Comparator: Morbidly Obese Transversus Abdominis Plane Block
Transversus Abdominis Plane Block for pain control.
Procedure: Ultrasound-guided pain block
Ultrasound-guided pain block after cesarean section
Device: Ultrasound Machine
Ultrasound machine used to guide the nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative time to rescue analgesia requirement
Time Frame: 24 hours
Time
24 hours

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Warda Ali, Al-Azhar University, Assiut, Egypt

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 (Estimated)

March 10, 2024

Primary Completion (Estimated)

September 10, 2024

Study Completion (Estimated)

September 10, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MSR/AZAST/AIP029/22/222/8/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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