TAPB vs QLBII for Kidney Transplantation Procedure

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Procedure: Quadratus Lumborum Block type II; Procedure: Transversus Abdominalis Plane Block; Device: Ultraplex; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02783586

TAPB/QLB-WAW/OLS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Kidney transplantation procedure with anatomical urinary outlet
2. Written informed consent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

Quadratus Lumborum Block type II

Experimental group

Description:

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

Treatment:

Device: Ultraplex

Drug: Bupivacaine

Procedure: Quadratus Lumborum Block type II

Transversus Abdominalis Plane Block

Active Comparator group

Description:

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

Treatment:

Device: Ultraplex

Drug: Bupivacaine

Procedure: Transversus Abdominalis Plane Block