PQLB vs TFPB in HALDN

NCT07852663 | Not Yet Recruiting

• 1 other identifier: 2026.314.IRB1.019
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized non-inferiority trial is designed to compare postoperative analgesic effect of transversalis fascia plane block and posterior quadratus lumborum block in hand assisted laparoscopic donor nephrectomy. Posoperative opioid consumption, numeric rating scale pain scores and adverse effects will be assessed during the trial.

Conditions

Analgesia; Postoperative Pain; Fascial Plane Block; Quadratus Lumborum Block; Donor Nephrectomy; Transversalis Fascia Plane Block

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption for 24 hours

  The primary outcome is cumulative opioid consumption from the end of surgery through postoperative hour 24, expressed as IV morphine equivalents. Postoperative opioids will be converted to IV morphine equivalents using the ENCORE Study conversion table. The following conversion factors will be used: IV fentanyl: dose in micrograms × 0.066 = IV morphine equivalents in mg. IV tramadol: dose in mg × 0.1 = IV morphine equivalents in mg.

  postoperative 24 hours

Secondary Outcomes (4)

• postoperative opioid consumption for 48 hours

  postoperative 48 hours

• pain score

  postoperative 48 hours

• adverse effects

  postoperative 48 hours

• patient satisfaction

  postoperative 48 hours

Study Arms (2)

PQLB

EXPERIMENTAL

Posterior quadratus lumborum block will be administered by the senior anesthesiologist, following the anesthesia induction and before the surgical incision.

Procedure: Quadratus Lumborum Block type 2

TFPB

ACTIVE COMPARATOR

Transversalis fascia plane block will be administered by the senior anesthesiologist, following the anesthesia induction and before the surgical incision.

Procedure: Transversalis Fascia Plane Block

Interventions

Quadratus Lumborum Block type 2 PROCEDURE

Posterior Quadratus Lumborum Block Technique A 2-6 MHz convex ultrasound probe will be positioned parallel to and over the iliac crest. Anterior and posterior scanning will identify the quadratus lumborum, psoas major, transversus abdominis, external and internal oblique muscles, lumbar vertebral body and transverse process, and perirenal adipose tissue. An 80-mm Stimuplex needle will be advanced in-plane under continuous ultrasound visualization. After negative aspiration, 30 mL of 0.25% bupivacaine will be injected into the posterior fascial plane of the quadratus lumborum muscle. Spread of the solution will be observed continuously using ultrasound, with repeated aspiration during injection.

Also known as: QLB-2, PQLB, Posterior quadratus lumborum block

PQLB

Transversalis Fascia Plane Block PROCEDURE

Transversalis fascia plane block administration technique: A 2-6 MHz convex ultrasound probe will be positioned parallel to and over the iliac crest. Anterior and posterior scanning will identify the quadratus lumborum, psoas major, transversus abdominis, external and internal oblique muscles, lumbar vertebral body and transverse process, and perirenal adipose tissue. An 80-mm Stimuplex needle will be advanced in-plane under continuous ultrasound visualization. After negative aspiration, 30 mL of 0.25% bupivacaine will be injected over the perirenal adipose tissue beneath the transversus abdominis fascia. Spread of the solution will be observed continuously using ultrasound, with repeated aspiration during injection to reduce the risk of intravascular administration.

Also known as: TFPB

TFPB

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Approved and scheduled for hand-assisted laparoscopic donor nephrectomy.
• Aged 18-84 years.
• Classified as ASA physical status I-II.
• Able to provide written informed consent.
• Written informed consent obtained before any study-specific procedure.

You may not qualify if:

• Allergy to any study medication.
• Chronic use of opioids or opioid-receptor agonists.
• History of psychiatric illness
• Chronic organ failure.
• Inability to communicate sufficiently for informed consent or outcome assessment.
• Refusal of the study intervention or follow-up.

Sponsors & Collaborators

• Koc University Hospital: lead
• Koç University School of Medicine: collaborator

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (3)

• Ozkalayci O, Karakaya MA, Yenigun Y, Cetin S, Darcin K, Akyollu B, Arpali E, Kocak B, Gurkan Y. Effects of erector spinae plane block on opioid consumption in patients undergoing hand-assisted laparoscopic donor nephrectomy: a randomized controlled trial. Minerva Anestesiol. 2024 Mar;90(3):154-161. doi: 10.23736/S0375-9393.23.17706-6. Epub 2024 Feb 2.

  PMID: 38305014 BACKGROUND

• Dupuis M, Bacci A, Adolle A, Sourd D, Vilotitch A, Bouzat P. Regional Analgesia Through Posterior Quadratus Lumborum Block in Laparoscopic and Robot-Assisted Nephrectomies: A Retrospective Observational Study. Anesth Analg. 2026 Feb 1;142(2):425-428. doi: 10.1213/ANE.0000000000007702. Epub 2025 Aug 29. No abstract available.

  PMID: 40880271 BACKGROUND

• De Cassai A, Dost B, Tulgar S, Ciftci B, Diwan S, Gurkan Y. Regional Anaesthesia Techniques in Liver and Kidney Transplantation: A Narrative Review in Donors and Recipients. Turk J Anaesthesiol Reanim. 2026 Aug 28;54(4):236-247. doi: 10.4274/TJAR.2026.262509.

  PMID: 42664388 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Central Study Contacts

Eren Y AÇIKALIN, MD

CONTACT

+90 533 747 21 48; erenyacikalin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Manual envelope randomization will be used. An anesthesia technician who is independent of the trial will prepare the allocation envelopes before recruitment begins.The preparing technician will place one card into each identical,Participants, intraoperative and postoperative anesthesia personnel involved in clinical follow-up, the surgical team, pain-service personnel, and outcome assessors will remain blinded to treatment allocation. Block-specific documentation and the restricted randomization log will be kept separately from the clinical follow-up file. The block anesthesiologist will not disclose the allocation and will not participate in any other role in the study or in the patient management, follow-up, outcome assessment, data entry, or statistical analysis of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in aneshtesiology and reanimation department

Model Details: Eligible participants will be enrolled consecutively and allocated in a 1:1 ratio to TFPB or PQLB. The anesthesiologist performing the block will be aware of the treatment allocation but will have no other role in the study or in the patient management, follow-up, outcome assessment, data entry, or statistical analysis of the study. Same senior anesthesiologist that is experienced in both block technique will administer both blocks in the trial.

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)