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NCT Number: NCT02783586

TAPB vs QLBII for Kidney Transplantation Procedure

The main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic agent to the paravertebral space. It may produce extensive analgesia and better pain control.

Previews studies shoved the effectiveness of TAPB in kidney transplantation procedure (KTX) by reducing opioids requirements during and after the operation. QLB was not evaluating in KTX procedure yet, but it reduced postoperative morphine requirement after cesarean section under spinal anaesthesia.

The aim of this prospective, randomised controlled, multicenter, clinical study is to compare the perioperative analgesic efficacy of QLB and TAPB in patients who had KTX under balanced (general and regional) anaesthesia.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw

Warsaw, 02-005, Poland

About this study

After Bioethical Committee of Medical University of Warsaw approval, informed written consent will be obtained from all patients.

A sample size of 104 patients was calculated to obtain at list 25% reduction of fentanyl usage in QLBII group with 0,05% significance and power of 0,8. Consenting patients, scheduled to KTX procedure under general anaesthesia will be randomly assigned (1:1) according to the computer -generated randomization list with permuted blocks (block sizes: 20, 20, 24, 40) to receive 20ml of 0,25% Bupivacaine with epinephrine ipsilaterally to the operation side in QLBII or TAPB after the general anaesthesia induction and before the surgery starts. All the blocks will be performed in the supine patients position, under ultrasound guidance for both techniques. The correct spread of injectate will be confirmed with ultrasound.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney transplantation procedure with anatomical urinary outlet
  • Written informed consent

Exclusion criteria

  • Patients' refusal
  • Known allergies to study medication
  • Inability to comprehend or participate in pain scoring scale
  • Inability to use intravenous patient controlled analgesia system
  • Anatomic, posttraumatic and postoperative deformations could possibly affect the spread of local anesthetic in transversus abdominalis plane or quadratus lumborum muscle plane.
  • Transversus abdominalis plane or quadratus lumborum muscle plane not seen in ultrasound examination.

Treatment and study plan

Quadratus Lumborum Block type II

Procedure

Local anaesthetic injection on the posterior border of the quadratus lumborum muscle

Transversus Abdominalis Plane Block

Procedure

Local anaesthetic injection between internal oblique and transversus abdominis muscle

Bupivacaine

Drug

20 ml of bupivacaine with adrenaline

Other names: Marcaine

Ultraplex

Device

A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.

Primary outcomes

  1. Total postoperative fentanyl usage

    Time frame: 24 hours

    Total cumulative fentanyl dose used in the first 24 hours after surgery

Secondary outcomes

  1. Time to first analgesic (TTFA)

    Time frame: 24 hours

    Time from the end of surgery to the first postoperative intravenous fentanyl administered from intravenous patient controlled analgesia ( IVPCA) device.

  2. Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery

    Time frame: 24 hours

    NRS range from 0 for no pain to 10 for worst pain imaginable.

  3. Nausea or vomiting

    Time frame: 24 hours

    0- no nausea; 1- mild nausea; 2- moderate nausea; 3- severe nausea or vomiting

  4. Sedation Level

    Time frame: 24 hours

    1 - responds to normal verbal communication; 2 - drowsy, but responds to verbal communication; 3- asleep, but awakes with verbal communication; 4- asleep, awakens with mild physical stimulation. 5- asleep, unresponsive to physical stimulation.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Ultrasound Guided Transversus Abdominalis Plane Block ( TAPB) Versus Quadratus Lumborum Type II Block (QLBII) in Perioperative Analgesia for Kidney Transplantation Procedure: Clinical Randomized Multicenter Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 26, 2016
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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