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NCT06292832 Clinical Trial

Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control

Cesarean Section Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06292832
Other study ID # MSR/AZAST/AIP029/22/222/8/2023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 10, 2024
Est. completion date September 10, 2024

Study information
Verified date February 2024
Source Al-Azhar University
Contact Warda Ali
Phone 00109939124
Email warda2001@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 68
Est. completion date September 10, 2024
Est. primary completion date September 10, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound-guided pain block
Ultrasound-guided pain block after cesarean section
Device:
• Ultrasound Machine
Ultrasound machine used to guide the nerve block.

Locations
Country Name City State
Egypt Al-Azhar University Assiut

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative time to rescue analgesia requirement Time 24 hours
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