Comparison of the Analgesic Effects of TFPB in Renal Transplantation Surgery

April 27, 2026 updated by: Atakan Sezgi, Ankara Etlik City Hospital

Comparison of the Analgesic Effects of Transversalis Fascia Plane Block in Renal Transplantation Surgery

Renal transplantation is a major surgical procedure associated with significant postoperative pain, particularly due to lower abdominal incision, deep tissue dissection, and extensive surgical manipulation. Effective postoperative pain control is therefore of great importance in this patient population, as inadequate analgesia may impair early mobilization, delay recovery, increase opioid consumption, and contribute to opioid-related adverse effects. In addition, optimal analgesic management may improve patient comfort and support enhanced postoperative outcomes.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare the analgesic effectiveness of transversalis fascia plane block in the postoperative period in patients who underwent renal transplantation.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

50

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

Study Contact Backup

Study Locations

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:

  • Patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) score III
  • Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

  • Patients under 18 and over 65 years of age
  • Patients with an ASA score other than III
  • Patients with a history of bleeding diathesis
  • BMI below 18 or above 30 kg/m2

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
Active Comparator: Transversalis Fascia Plane Block Group

After the linear ultrasound (US) probe will be placed transversely above the iliac crest on the side of surgery, the abdominal wall muscle layers will be identified and the probe will be moved posteriorly until the transversus abdominis muscle and the transversalis fascia are visualized. A block needle will then be advanced using an in-plane technique, and after negative aspiration, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the fascial plane between the transversus abdominis muscle and the transversalis fascia. Proper spread of the local anesthetic in this plane will be confirmed by ultrasound imaging.

This procedure will be performed unilaterally on the surgical side. The standard intraoperative analgesic regimen will consist of intravenous tramadol (1 mg/kg) administered both before the incision and at the end of the procedure, with intravenous paracetamol (10 mg/kg) given exclusively at the end of the surgery.

This procedure will be performed unilaterally on the surgical side. 30 ml of 0.25% bupivacaine will be injected for ultrasound-guided transversalis fascia plane block application.

The standard intraoperative analgesic regimen will consist of intravenous tramadol (1 mg/kg) administered both before the incision and at the end of the procedure, with intravenous paracetamol (10 mg/kg) given exclusively at the end of the surgery.

Active Comparator: Control Group

Participants in the control group will not receive any regional block intervention.

The standard intraoperative analgesic regimen will consist of intravenous tramadol (1 mg/kg) administered both before the incision and at the end of the procedure, with intravenous paracetamol (10 mg/kg) given exclusively at the end of the surgery.

No peripheral nerve block will be performed.

The standard intraoperative analgesic regimen will consist of intravenous tramadol (1 mg/kg) administered both before the incision and at the end of the procedure, with intravenous paracetamol (10 mg/kg) given exclusively at the end of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: On the operation day
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 12th, and 24th hours after surgery
On the operation day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption
Time Frame: Intraoperative period
Remifentanil consumption for intraoperative period will be recorded
Intraoperative period
Postoperative Opioid Consumption
Time Frame: On the operation day
Opioid consumption for 24 hours will be recorded
On the operation day

Collaborators and Investigators

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

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)

April 27, 2026

Primary Completion (Estimated)

October 4, 2027

Study Completion (Estimated)

October 18, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

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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