TAPB vs QLBII for Kidney Transplantation Procedure

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Quadratus Lumborum Block type II; Procedure: Transversus Abdominalis Plane Block; Drug: Bupivacaine; Device: Ultraplex

• Registration Number: NCT02783586
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04-08
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Primary Completion: 2017-05-29
• Study Completion: 2017-05-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus Lumborum Block type II	Ultraplex	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
Transversus Abdominalis Plane Block	Ultraplex	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
Quadratus Lumborum Block type II	Quadratus Lumborum Block type II	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
Transversus Abdominalis Plane Block	Transversus Abdominalis Plane Block	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
Quadratus Lumborum Block type II	Bupivacaine	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
Transversus Abdominalis Plane Block	Bupivacaine	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

Primary Outcome Measures

Name	Time	Method
Total postoperative fentanyl usage	24 hours	Total cumulative fentanyl dose used in the first 24 hours after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw; 🇵🇱 Warsaw, Poland