PQLB vs TFPB in HALDN

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorKoc University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to any study medication.

Chronic use of opioids or opioid-receptor agonists.

History of psychiatric illness

Chronic organ failure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quadratus Lumborum Block type 2

    Procedure/Surgery

    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 Block

    Procedure/Surgery

    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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: PQLBExperimental treatment 1 intervention
Group B: TFPBActive comparator 1 intervention

Trial outcomes

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.

Time frame
postoperative 24 hours

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
postoperative 48 hours
4

patient satisfaction

6\. 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.

Time frame
postoperative 48 hours

Other outcomes

Sponsors and contacts

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Koc University Hospital

Lead sponsor

Koç University

Sponsor institution

Koç University School of Medicine

Collaborator

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