TAPB vs QLBII for Kidney Transplantation Procedure

NCT02783586 | Completed Phase 4

• 1 other identifier: TAPB/QLB-WAW/OLS
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total postoperative fentanyl usage

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

  24 hours

Secondary Outcomes (4)

• Time to first analgesic (TTFA)

  24 hours

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

  24 hours

• Nausea or vomiting

  24 hours

• Sedation Level

  24 hours

Study Arms (2)

Quadratus Lumborum Block type II

EXPERIMENTAL

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; Drug: Bupivacaine; Device: Ultraplex

Transversus Abdominalis Plane Block

ACTIVE COMPARATOR

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; Drug: Bupivacaine; Device: Ultraplex

Interventions

Quadratus Lumborum Block type II PROCEDURE

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

Quadratus Lumborum Block type II

Transversus Abdominalis Plane Block PROCEDURE

Local anaesthetic injection between internal oblique and transversus abdominis muscle

Transversus Abdominalis Plane Block

Bupivacaine DRUG

20 ml of bupivacaine with adrenaline

Also known as: Marcaine

Quadratus Lumborum Block type II; Transversus Abdominalis Plane Block

Ultraplex DEVICE

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

Quadratus Lumborum Block type II; Transversus Abdominalis Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, 02-005, Poland

Location

Related Publications (1)

• 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.

  PMID: 32175985 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marcin Kolacz, MD,PhD

  Medical University of Warsaw

  STUDY DIRECTOR

• Marcin Mieszkowski, MD

  Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 26, 2016
• Study Start: April 8, 2016
• Primary Completion: May 29, 2017
• Study Completion: May 30, 2017
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)