TAPB vs QLBII for Kidney Transplantation Procedure

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Quadratus Lumborum Block type II; Drug: Bupivacaine; Device: Ultraplex; Procedure: Transversus Abdominalis Plane Block

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-005
    • I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Quadratus Lumborum Block type II; Local anaesthetic injection on the posterior border of the quadratus lumborum muscle; Drug: Bupivacaine; 20 ml of bupivacaine with adrenaline; Other Names: Marcaine; Device: Ultraplex; A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
Active Comparator: 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	Drug: Bupivacaine; 20 ml of bupivacaine with adrenaline; Other Names: Marcaine; Device: Ultraplex; A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.; Procedure: Transversus Abdominalis Plane Block; Local anaesthetic injection between internal oblique and transversus abdominis muscle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Director: Marcin Kolacz, MD,PhD, Medical University of Warsaw; Principal Investigator: Marcin Mieszkowski, MD, Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland

Publications and helpful links

General Publications

• Kolacz M, Mieszkowski M, Janiak M, Zagorski K, Byszewska B, Weryk-Dysko M, Onichimowski D, Trzebicki J. Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia in renal transplantation: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):773-789. doi: 10.1097/EJA.0000000000001193.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2016
• Primary Completion (Actual): May 29, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: TAPB/QLB-WAW/OLS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO