TAPB vs QLBII for Kidney Transplantation Procedure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Quadratus Lumborum Block type II
* Procedure: Transversus Abdominalis Plane Block
* Drug: Bupivacaine
* Device: Ultraplex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadratus Lumborum Block type II<br>Unilateral ultrasound guidance QLB on the operated side after induction of general anaesthesia - 20 ml of 0,25%bupivacaine with adrenaline injected with ultraplex needle | Procedure: Quadratus Lumborum Block type II<br>* Local anaesthetic injection on the posterior border of the quadratus lumborum muscle<br>Drug: Bupivacaine<br>* 20 ml of bupivacaine with adrenaline<br>* Other names: Marcaine;Device: Ultraplex<br>* A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.<br>|
| Active Comparator: Transversus Abdominalis Plane Block<br>Unilateral ultrasound guidance TAPB on the operated side after induction of general anaesthesia - 20 ml of 0,25% bupivacaine with adrenaline injected with ultraplex needle | Procedure: Transversus Abdominalis Plane Block<br>* Local anaesthetic injection between internal oblique and transversus abdominis muscle<br>Drug: Bupivacaine<br>* 20 ml of bupivacaine with adrenaline<br>* Other names: Marcaine;Device: Ultraplex<br>* A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative fentanyl usage | Total cumulative fentanyl dose used in the first 24 hours after surgery | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic (TTFA) | Time from the end of surgery to the first postoperative intravenous fentanyl administered from intravenous patient controlled analgesia ( IVPCA) device. | 24 hours | 
| Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery | NRS range from 0 for no pain to 10 for worst pain imaginable. | 24 hours | 
| Nausea or vomiting | 0- no nausea; 1- mild nausea; 2- moderate nausea; 3- severe nausea or vomiting | 24 hours | 
| Sedation Level | 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. | 24 hours |