- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542028
Comparison of the Analgesic Effects of TFPB in Renal Transplantation Surgery
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Atakan Sezgi
- Phone Number: 00905323327000
- Email: kansezgi@gmail.com
Study Contact Backup
- Name: Jülide Ergil
- Phone Number: 00905323469216
- Email: julideergil@hotmail.com
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey (Türkiye), 06000
- Recruiting
- Atakan Sezgi
-
Contact:
- Jülide Ergil, Professor
- Phone Number: 00905323469216
- Email: julideergil@hotmail.com
-
Contact:
- Atakan Sezgi, M.D.
- Phone Number: 00905323327000
- Email: kansezgi@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK-2026-070
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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