Comparison of the Analgesic Effects of TFPB in Renal Transplantation Surgery
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
April 21, 2026
CompletedStudy Start
First participant enrolled
April 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 18, 2027
April 28, 2026
April 1, 2026
1.4 years
April 14, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Scores
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 Outcomes (2)
Intraoperative opioid consumption
Intraoperative period
Postoperative Opioid Consumption
On the operation day
Study Arms (2)
Transversalis Fascia Plane Block Group
ACTIVE COMPARATORAfter 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.
Control Group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) score III
- Body Mass Index (BMI) between 18-30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atakan Sezgi
Altındağ, Ankara, 06000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2026
First Posted
April 21, 2026
Study Start
April 27, 2026
Primary Completion (Estimated)
October 4, 2027
Study Completion (Estimated)
October 18, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04