Renal TransplantationNCT07542028
Comparison of the Analgesic Effects of TFPB in Renal Transplantation Surgery
A study testing Transversalis Fascia Plane Block Group in people with Renal Transplantation and Peripheral Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation, Peripheral Nerve Block, Pain Management
- What is being tested?
- Transversalis Fascia Plane Block Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2026to 18 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) score III
- Body Mass Index (BMI) between 18-30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atakan Sezgi
Altındağ, Ankara, 06000
Atakan Sezgi, M.D., 00905323327000, kansezgi@gmail.com
Jülide Ergil, Professor, 00905323469216, julideergil@hotmail.com
About this study
Official title: 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.
- Being tested
- Transversalis Fascia Plane Block Group, Control Group
- Keywords
- Renal Transplantation, Transversalis Fascia Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis Fascia Plane Block GroupProcedure or 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.
Control GroupProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Transversalis Fascia Plane Block Group | Active comparator | 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. Receives: Procedure: Transversalis Fascia Plane Block Group |
| Control Group | Active comparator | 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. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: On the operation day
Secondary outcomes (2)
Intraoperative opioid consumption
Remifentanil consumption for intraoperative period will be recorded
Measured: Intraoperative period
Postoperative Opioid Consumption
Opioid consumption for 24 hours will be recorded
Measured: On the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start27 Apr 2026
- Primary completion4 Oct 2027 (estimated)
- Study completion18 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542028
- Sponsor's protocol ID
- AEŞH-EK-2026-070
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Transversalis Fascia Plane Block in Renal Transplantation Surgery
- ClinicalTrials.gov ID
- NCT07542028
- Acronym / sponsor ID
- AEŞH-EK-2026-070
- Keywords
- Renal Transplantation, Transversalis Fascia Plane Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 4 Oct 2027 (estimated)
- Study completion
- 18 Oct 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversalis Fascia Plane Block Group | Active comparator | Procedure: Transversalis Fascia Plane Block GroupAfter 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 comparator | Procedure: Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) score III
- Body Mass Index (BMI) between 18-30 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversalis Fascia Plane Block GroupThis 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. | Procedure or surgery | Transversalis Fascia Plane Block Group |
| Control GroupNo 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. | Procedure or surgery | Control Group |
Primary outcome
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
2 secondary outcomes
Intraoperative opioid consumption
Time frame: Intraoperative period
Postoperative Opioid Consumption
Time frame: On the operation day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversalis Fascia Plane Block Group in people with Renal Transplantation and Peripheral Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atakan Sezgi (00905323327000, kansezgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: On the operation day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.