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AnalgesiaNCT07852663

PQLB vs TFPB in HALDN

A study testing Quadratus Lumborum Block type 2 and Transversalis Fascia Plane Block in people with Analgesia and Donor Nephrectomy, run by Koc University Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Analgesia, Donor Nephrectomy, Postoperative Pain
What is being tested?
Quadratus Lumborum Block type 2 and Transversalis Fascia Plane Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2026to Apr 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 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eren Y AÇIKALIN, MD contact

+90 533 747 21 48

erenyacikalin@gmail.com

Turkey (Türkiye)1 site
  • Koç University Hospital

    Istanbul, Zeytinburnu, 34010

    Eren Yavuz AÇIKALIN, +90 533 747 21 48, erenyacikalin@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Posterior Quadratus Lumborum Block and Transversalis Fascia Plane Block on Opioid Consumption in Hand-Assisted Laparoscopic Donor Nephrectomy: A Randomized, Double-Blind, Non-Inferiority Trial

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.

Read the detailed description

Hand-assisted laparoscopic donor nephrectomy (HALDN) is a widely used technique for kidney donor surgeries. Management of postoperative pain is important to provide patient comfort. Main components of postoperative pain is from incision sides. Regional anesthesia techniques may reduce postoperative opioid requirements in this patient group, but the optimal block for this procedure has not been established.

A competed but not yet published study in our clinic found that transversalis fascia plane block significantly reduced analgesic requirements after HALDN. Its a deep block, that involves injection below transversalis fascia and above perirenal fat tissue. Its location can be seen relatively close to the important structures of such as peritoneum and retroperitenoum. Posterior quadratus lumborum block (PQLB, also known as quadratus lumborum block -2 or QLB-2) is considered effective in renal surgery for other indications and PQLB may provide analgesia comparable to TFPB for HALDN surgery. Possible benefit of PQLB over TFPB is superficial anatomical location of PQLB and its relative distance to areas such as retroperitoneum and peritoneum. Results in our center shows TFPB effective in HALDN procedure, therefore it is selected as the control group intervention This trial is designed to determine whether PQLB is not inferior to TFPB for cumulative opioid consumption during the first 24 postoperative hours for HALDN surgery. Opioid consumption, pain scores and adverse effects through first 48 hours postoperatively and patient satisfaction at 48th hour will be evaluated as a secondary outcome to describe the duration of postoperative analgesic effect.

Routine preanesthetic premedication with midazolam 0.03 mg/kg will be administered to both study groups. Anesthesia will be induced with fentanyl 1-2 micrograms/kg IV, propofol 1-2 mg/kg IV, and rocuronium 0.9-1.2 mg/kg IV.

General anesthesia will be maintained with 40% inspired oxygen, desflurane at approximately 1 minimum alveolar concentration, and a remifentanil infusion at 0 - 0.02 micrograms/kg/min. The actual doses of all intraoperative opioids will be recorded. Intraoperative fentanyl and remifentanil administered before the end of surgery will not be included in the primary outcome.

The assigned block will be performed after induction of general anesthesia and before surgical incision, with the participant in the lateral position and the operative side facing upward.

Standard anesthesia monitoring will continue throughout block placement and until the surgery ends.

At the end of surgery, all participants will receive paracetamol 1 g IV and morphine 0.05 mg/kg IV in addition to regional anesthesia technique as standardized multimodal analgesia regiment. The end-of-surgery morphine dose will be included in cumulative postoperative opioid consumption.

Participants will be extubated in the operation room when clinically appropriate and transferred to the post-anesthesia care unit.

In the PACU, a morphine PCA device will be started using a 1 mg IV bolus, an 8-minute lockout interval, and no basal infusion. Device-generated records will be used to determine PCA consumption. In PACU, if NRS is greater than or equal to 4 is observed, fentanyl 50 micrograms IV will be administered up to three times at 15-minute intervals. All fentanyl administered in the PACU will be included in cumulative postoperative opioid consumption.

For 48 hours, all participants will receive paracetamol 1 g IV three times daily and morphine PCA using the same settings. In surgical ward, If NRS is greater than or equal to 4 is observed, tramadol 100 mg IV will be administered as rescue analgesia in accordance with institutional prescribing limits.

Every rescue dose and any additional analgesic treatment required for clinical care will be recorded. Tramadol will be converted to IV morphine equivalents and included in cumulative postoperative opioid consumption.

Morphine PCA cumulative consumption, rescue opioid and analgesic use, NRS at rest, NRS during cough, and opioid-related and block-related adverse events will be assessed at postoperative hours 1, 3, 6, 12, 24, and 48.

Patient satisfaction with postoperative pain management will be assessed at postoperative hour 48.

Protocol deviations, withdrawal, loss to follow-up, unblinding, and missing assessments will be recorded whenever they occur.

Being tested
Quadratus Lumborum Block type 2, Transversalis Fascia Plane Block
Medical subject headings
Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadratus Lumborum Block type 2Procedure or surgery

    Also called QLB-2, PQLB, Posterior quadratus lumborum block

    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.

  • Transversalis Fascia Plane BlockProcedure or surgery

    Also called TFPB

    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.

Study groups in NCT07852663
Study groupRoleWhat they receive
PQLBExperimentalPosterior quadratus lumborum block will be administered by the senior anesthesiologist, following the anesthesia induction and before the surgical incision.
Receives: Procedure: Quadratus Lumborum Block type 2
TFPBActive comparatorTransversalis fascia plane block will be administered by the senior anesthesiologist, following the anesthesia induction and before the surgical incision.
Receives: Procedure: Transversalis Fascia Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: postoperative 24 hours

Secondary outcomes (4)
  1. postoperative opioid consumption for 48 hours

    Cumulative opioid consumption from the end of surgery through postoperative hour 48, expressed as IV morphine equivalents. Assesment will be made at postoperative 1,3,6,12,24 and 48th hour.

    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.

    Measured: postoperative 48 hours

  2. pain score

    Pain will be assesed by NRS scores at rest and cough, expressed drom 0 to 10. Assesment will be made at postoperative 1,3,6,12,24 and 48th hour.

    Measured: postoperative 48 hours

  3. adverse effects

    Incidence and details of nausea, vomiting, pruritus, allergic reaction, sedation, respiratory depression, urinary retention, LAST, bleeding or hematoma, infection, persistent sensory or motor deficit, nerve injury, visceral or renal injury, and any other opioid or block-related adverse event through 48 hours.

    Measured: postoperative 48 hours

  4. patient satisfaction

    1. Patient satisfaction at 48 hours, assessed by asking: "How satisfied were you with your postoperative pain management?" The response will range from 0 to 10.

    Measured: postoperative 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852663
Sponsor's protocol ID
2026.314.IRB1.019
Status last verified
Oct 2026
First submitted
25 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38305014
  • 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.

    PubMed 40880271
  • 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.

    PubMed 42664388

Questions about this trial

What is this clinical trial studying?

A study testing Quadratus Lumborum Block type 2 and Transversalis Fascia Plane Block in people with Analgesia and Donor Nephrectomy, run by Koc University 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Oct 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 Eren Y AÇIKALIN, MD (+90 533 747 21 48, erenyacikalin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative opioid consumption for 24 hours (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07852663, which also lists 3 linked publications.

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 8 Oct 2026.

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