NCT06292832

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 20, 2024

Last Update Submit

February 27, 2024

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • postoperative time to rescue analgesia requirement

    Time

    24 hours

Study Arms (4)

Obese Spinae Plane Block

ACTIVE COMPARATOR

Spinae Plane Block for pain control

Procedure: Ultrasound-guided pain blockDevice: Ultrasound Machine

Obese Transversus Abdominis Plane Block

ACTIVE COMPARATOR

Transversus Abdominis Plane Block for pain control.

Procedure: Ultrasound-guided pain blockDevice: Ultrasound Machine

Morbidly Obese Spinae Plane Block

ACTIVE COMPARATOR

Spinae Plane Block for pain control

Procedure: Ultrasound-guided pain blockDevice: Ultrasound Machine

Morbidly Obese Transversus Abdominis Plane Block

ACTIVE COMPARATOR

Transversus Abdominis Plane Block for pain control.

Procedure: Ultrasound-guided pain blockDevice: Ultrasound Machine

Interventions

Ultrasound-guided pain blockPROCEDURE

Ultrasound-guided pain block after cesarean section

Morbidly Obese Spinae Plane BlockMorbidly Obese Transversus Abdominis Plane BlockObese Spinae Plane BlockObese Transversus Abdominis Plane Block
Ultrasound MachineDEVICE

Ultrasound machine used to guide the nerve block.

Morbidly Obese Spinae Plane BlockMorbidly Obese Transversus Abdominis Plane BlockObese Spinae Plane BlockObese Transversus Abdominis Plane Block

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Asyut, Egypt

Location

Study Officials

  • Warda Ali

    Al-Azhar University, Assiut, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Warda Ali

CONTACT

00109939124warda2001@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 20, 2024

First Posted

March 5, 2024

Study Start

March 10, 2024

Primary Completion

September 10, 2024

Study Completion

September 10, 2024

Last Updated

March 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)