Transversalis Fascia Plane Block Versus Surgical Wound Infiltration for Postoperative Analgesia in Open Inguinal Hernia Repair (TFPB-WIN)

November 15, 2025 updated by: Ilke Tamdogan, Ondokuz Mayıs University

Analgesic Efficacy of Ultrasound-Guided Transversalis Fascia Plane Block Versus Surgical Wound Infiltration After Open Inguinal Hernia Surgery: A Randomized Controlled Trial

The purpose of this clinical trial is to evaluate whether two different analgesic techniques - ultrasound-guided Transversalis Fascia Plane Block (TFPB) and surgical wound infiltration - can improve postoperative pain control in adult patients undergoing open inguinal hernia repair.

The key questions that this study aims to answer are:

Does TFPB reduce total intravenous opioid consumption within the first 24 postoperative hours compared with wound infiltration?

Does TFPB improve postoperative pain scores at rest and during movement compared with wound infiltration?

Does TFPB improve patient satisfaction, reduce the need for rescue analgesics, and enhance overall postoperative recovery quality?

If there is a comparison group:

The investigators will compare the effects of TFPB with wound infiltration to determine whether either technique provides superior postoperative analgesia and reduces opioid requirements.

Participants will be asked to:

Undergo open inguinal hernia repair under spinal anesthesia.

Be randomly assigned to one of two groups:

TFPB Group: Receive an ultrasound-guided transversalis fascia plane block with local anesthetic.

Wound Infiltration Group: Receive local anesthetic infiltration performed by the surgeon along the incision line.

Postoperatively:

Report pain scores at defined intervals.

Receive standardized IV analgesia with documentation of opioid consumption.

Allow assessment of rescue analgesic requirement.

Be monitored for adverse events and recovery outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

worldwide. Inadequate analgesia in the early postoperative period may lead to delayed mobilization, prolonged hospital stay, and increased opioid consumption. Accordingly, current international guidelines recommend multimodal analgesia strategies and the use of regional anesthesia techniques when appropriate (1). Surgical wound infiltration is a frequently used component of multimodal analgesia in groin surgery; however, its effectiveness may vary depending on the timing of administration, technique, and the homogeneity of local anesthetic spread, and its duration of action is often limited. Recent clinical series continue to report significant postoperative pain and notable opioid requirements following primary unilateral open repair (1).

In recent years, ultrasound-guided fascial plane blocks have gained increasing attention due to their more predictable spread and potential to provide longer-lasting analgesia (2). The Transversalis Fascia Plane (TFP) block is a truncal block achieved by injecting local anesthetic between the transversus abdominis muscle and the transversalis fascia, thereby targeting the T12-L1 spinal nerves. This anatomical distribution provides a strong physiological rationale for its use in inguinal region surgery (3).

Several studies have demonstrated that the TFP block can reduce postoperative pain scores and rescue analgesic requirements in pediatric herniotomy and adult groin surgeries (4). However, randomized controlled trials directly comparing the TFP block with surgical wound infiltration in open inguinal hernia repair remain limited. Existing evidence partly stems from comparisons with other fascial plane blocks (e.g., Quadratus Lumborum [QL], Transversus Abdominis Plane [TAP] block) or from studies in different types of groin surgery, such as subinguinal varicocelectomy (5-7). Therefore, whether the TFP block provides a clinically meaningful advantage over wound infiltration in open inguinal hernia repair is a clinically relevant question that remains to be definitively answered.

This study aims to compare the contribution of the Transversalis Fascia Plane Block (TFPB) and surgical wound infiltration to postoperative analgesia in patients undergoing elective unilateral open inguinal hernia repair. The primary hypothesis is that TFPB will reduce cumulative rescue opioid consumption during the first 24 postoperative hours compared with wound infiltration. The secondary hypotheses are that TFPB will decrease postoperative pain scores, prolong the time to first rescue analgesia, and improve patient satisfaction without increasing the incidence of postoperative nausea and vomiting (PONV) or other adverse events.

articipants will be randomized into one of two intervention arms.

In the TFPB group, an ultrasound-guided transversalis fascia plane block will be performed in the postoperative period using a standardized volume and concentration of local anesthetic.

In the Wound Infiltration group, local anesthetic will be infiltrated by the surgeon into the relevant layers of the incision site at the end of the surgery.

All patients will receive a standardized spinal anesthesia protocol and a uniform postoperative analgesia regimen. Postoperative pain scores and opioid consumption will be recorded at predefined time intervals. The investigators responsible for postoperative assessments will remain blinded to group allocation throughout the study.

Primary outcome measure:

Total opioid consumption during the first 24 postoperative hours.

Secondary outcome measures:

NRS pain scores at rest and during coughing, the number of patients requiring rescue analgesia, the incidence of postoperative nausea and vomiting, block-related complications, and overall patient satisfaction.

Study Type

Interventional

Enrollment (Estimated)

104

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 Contact

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

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Scheduled for elective unilateral open inguinal hernia repair
  • Planned anesthesia: spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Able to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Body mass index (BMI) > 35 kg/m²
  • Known hypersensitivity to local anesthetics used in the study (e.g., bupivacaine) or to analgesic medications
  • Coagulopathy
  • Infection or hematoma at the planned block site
  • Significant systemic disease (such as chronic kidney disease, hepatic failure, chronic obstructive pulmonary disease, etc.)
  • History of chronic pain or long-term analgesic use
  • Inability to use the patient-controlled analgesia system
  • Presence of psychiatric disorders
  • Refusal to participate in the study.
  • Cases with a surgical duration shorter than 30 minutes or longer than 180 minutes were excluded.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)
An ultrasound-guided Transversalis Fascia Plane Block will be performed by injecting a standardized volume and concentration of local anesthetic between the transversus abdominis muscle and the transversalis fascia. The block will be administered immediately after spinal anesthesia, prior to postoperative transfer. All other perioperative management and postoperative analgesia protocols will be identical to those in the comparison arm.
Procedure: Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)
An ultrasound-guided Transversalis Fascia Plane Block will be performed by injecting a standardized volume and concentration of local anesthetic between the transversus abdominis muscle and the transversalis fascia. The block will be administered immediately after spinal anesthesia, prior to postoperative transfer. All other perioperative management and postoperative analgesia protocols will be identical to those in the comparison arm.
Active Comparator: Surgical Wound Infiltration
At the end of surgery, the operating surgeon will infiltrate a standardized volume and concentration of local anesthetic into the relevant tissue layers of the surgical incision. The infiltration will be performed immediately after skin closure. Participants in this arm will receive the same spinal anesthesia and postoperative analgesia regimen as those in the TFPB group.
Procedure: Surgical Wound Infiltration
At the end of surgery, the operating surgeon will infiltrate a standardized volume and concentration of local anesthetic into the relevant tissue layers of the surgical incision. The infiltration will be performed immediately after skin closure. Participants in this arm will receive the same spinal anesthesia and postoperative analgesia regimen as those in the TFPB group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption within the first 24 postoperative hours
Time Frame: 0-24 hours after surgery
Cumulative amount of intravenous rescue opioid (e.g., tramadol or morphine equivalent dose) administered during the first 24 postoperative hours, recorded from the post-anesthesia care unit through postoperative hour 24.
0-24 hours after surgery

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

Collaborators

Giresun Training and Research Hospital

Investigators

  • Principal Investigator: İlke TAMDOGAN, Asst. Prof., Giresun University Faculty of Medicine

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INGHER2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ndividual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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