Back to results

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

Primary Purpose

Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)

Procedure/Surgery: Erector Spinae Plane Block (ESPB)

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Istanbul Basaksehir Cam and Sakura City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental: Transversus Abdominis Plane Block (TAPB)

Experimental: Erector Spinae Plane Block (ESPB)

Arm Description

patients received TAPB postoperatively

patients received ESPB postoperatively

Outcomes

Primary Outcome Measures

Percentage of patients needed for rescue analgesic agent (diclofenac)

Secondary Outcome Measures

Percentage of patients needed for rescue analgesic agent (opioid)

the dose of the opioid used

Percentage of patients experienced chronic pain

Full Information

NCT ID

NCT05625009

First Posted

November 11, 2022

Last Updated

May 3, 2023

Sponsor

Istanbul Saglik Bilimleri University

1. Study Identification

Unique Protocol Identification Number

NCT05625009

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 24, 2022 (Actual)

Primary Completion Date

January 24, 2023 (Actual)

Study Completion Date

April 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Saglik Bilimleri University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block, Transversus Abdominis Plane Block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Masking Description

The investigators who assessed pain scores postoperatively are blinded to the study groups Care providers on the yard are blinded to the study groups Outcome assessors are blinded to the study groups

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Transversus Abdominis Plane Block (TAPB)

Arm Type

Experimental

Arm Description

patients received TAPB postoperatively

Arm Title

Experimental: Erector Spinae Plane Block (ESPB)

Arm Type

Experimental

Arm Description

patients received ESPB postoperatively

Intervention Type

Procedure

Intervention Name(s)

Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)

Intervention Description

Patients received TAPB postoperatively

Intervention Type

Procedure

Intervention Name(s)

Procedure/Surgery: Erector Spinae Plane Block (ESPB)

Intervention Description

Patients received ESPB postoperatively

Primary Outcome Measure Information:

Title

Percentage of patients needed for rescue analgesic agent (diclofenac)

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Percentage of patients needed for rescue analgesic agent (opioid)

Time Frame

24 hours

Title

the dose of the opioid used

Time Frame

24 hours

Title

Percentage of patients experienced chronic pain

Time Frame

2 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

cesarean section

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Istanbul Basaksehir Cam and Sakura City Hospital

City

Istanbul

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs