Efficacy of US-guided TFPB in Open Gynecologic Surgery

May 13, 2026 updated by: PREEYAPHAN ARUNAKUL, Thammasat University

Efficacy of Ultrasound-guided Transversalis Fascia Plane Block (TFPB) in Controlling Postoperative Pain After Transverse Incision in Gynecologic Surgery

Transversalis fascia plane block (TFPB) has been studied and has shown to be very effective in controlling postoperative pain after caesarean section but has not been studied in open gynecologic surgery with transverse incision. Inadequate pain control after open gynecologic surgery is associated with negative consequences such as chronic pelvic pain. The investigators aimed to evaluate the efficacy of TFPB in controlling postoperative pain after open gynecologic surgery with transverse incision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial study in which comparing US-guided TFPB vs conventional pain control in open gynecologic surgery

Study Type

Interventional

Enrollment (Actual)

32

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 Locations

  • Thailand
      • Pathum Thani, Thailand, 12121
        • Department of Anesthesiology, Faculty of Medicine, Thammasat University

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who undergoing open gynecologic surgery under general anesthesia
  • Age 18 - 70 years
  • ASA Physical status I-III
  • Transverse incision

Exclusion Criteria:

  • Creatinine clearance is less than 30 ml/min
  • Body weight < 50 kg
  • Re-open surgery
  • Persistent chronic pelvic pain
  • Allergic to medications used in this study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Patients in control group will receive general anesthesia for open gynecologic surgery.
Experimental: TFPB
Patients in this study group will receive general anesthesia and US-guided bilateral TFPB after wound closure.
Procedure: US-guided transversalis fascia plane block
US-guided bilateral transversalis fascia plane block, using Sonotap 110 mm and 0.25% bupivacaine 20 ml on each side, will be done after wound closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative 24 hours morphine requirement
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain score
Time Frame: 1 hour, 6 hours, 24 hours
1 hour, 6 hours, 24 hours
Side effects from postoperative opioids
Time Frame: 24 hours
nausea vomiting, itching, respiratory depression
24 hours
Incidence of chronic pelvic pain
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT, Faculty of Medicine, Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 4, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-AN-1-062/67

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

product manufactured in and exported from the U.S.

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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