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Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control

NCT ID: NCT06292832

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-10

Study Completion Date

2024-09-10

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Obese Spinae Plane Block

Spinae Plane Block for pain control

Group Type ACTIVE_COMPARATOR

Ultrasound-guided pain block

Intervention Type PROCEDURE

Ultrasound-guided pain block after cesarean section

Ultrasound Machine

Intervention Type DEVICE

Ultrasound machine used to guide the nerve block.

Obese Transversus Abdominis Plane Block

Transversus Abdominis Plane Block for pain control.

Group Type ACTIVE_COMPARATOR

Ultrasound-guided pain block

Intervention Type PROCEDURE

Ultrasound-guided pain block after cesarean section

Ultrasound Machine

Intervention Type DEVICE

Ultrasound machine used to guide the nerve block.

Morbidly Obese Spinae Plane Block

Spinae Plane Block for pain control

Group Type ACTIVE_COMPARATOR

Ultrasound-guided pain block

Intervention Type PROCEDURE

Ultrasound-guided pain block after cesarean section

Ultrasound Machine

Intervention Type DEVICE

Ultrasound machine used to guide the nerve block.

Morbidly Obese Transversus Abdominis Plane Block

Transversus Abdominis Plane Block for pain control.

Group Type ACTIVE_COMPARATOR

Ultrasound-guided pain block

Intervention Type PROCEDURE

Ultrasound-guided pain block after cesarean section

Ultrasound Machine

Intervention Type DEVICE

Ultrasound machine used to guide the nerve block.

Interventions

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Ultrasound-guided pain block

Ultrasound-guided pain block after cesarean section

Intervention Type PROCEDURE

Ultrasound Machine

Ultrasound machine used to guide the nerve block.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Warda Demerdash Khalifa Ali

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Warda Ali

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University, Assiut, Egypt

Locations

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Al-Azhar University

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Warda Ali

Role: CONTACT

[email protected]
00109939124

Facility Contacts

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Warda Ali

Role: primary

[email protected]
010300020456

Other Identifiers

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MSR/AZAST/AIP029/22/222/8/2023

Identifier Type: -

Identifier Source: org_study_id

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