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TAPB vs QLBII for Kidney Transplantation Procedure

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Quadratus Lumborum Block type II
Transversus Abdominalis Plane Block
Bupivacaine
Ultraplex
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quadratus Lumborum Block type II

Transversus Abdominalis Plane Block

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Nausea or vomiting
0- no nausea; 1- mild nausea; 2- moderate nausea; 3- severe nausea or vomiting
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.

Full Information

First Posted
May 18, 2016
Last Updated
May 21, 2018
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02783586
Brief Title
TAPB vs QLBII for Kidney Transplantation Procedure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 8, 2016 (Actual)
Primary Completion Date
May 29, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum Block type II
Arm Type
Experimental
Arm 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
Arm Title
Transversus Abdominalis Plane Block
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block type II
Intervention Description
Local anaesthetic injection on the posterior border of the quadratus lumborum muscle
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominalis Plane Block
Intervention Description
Local anaesthetic injection between internal oblique and transversus abdominis muscle
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
20 ml of bupivacaine with adrenaline
Intervention Type
Device
Intervention Name(s)
Ultraplex
Intervention Description
A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
Primary Outcome Measure Information:
Title
Total postoperative fentanyl usage
Description
Total cumulative fentanyl dose used in the first 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to first analgesic (TTFA)
Description
Time from the end of surgery to the first postoperative intravenous fentanyl administered from intravenous patient controlled analgesia ( IVPCA) device.
Time Frame
24 hours
Title
Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery
Description
NRS range from 0 for no pain to 10 for worst pain imaginable.
Time Frame
24 hours
Title
Nausea or vomiting
Description
0- no nausea; 1- mild nausea; 2- moderate nausea; 3- severe nausea or vomiting
Time Frame
24 hours
Title
Sedation Level
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Kolacz, MD,PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marcin Mieszkowski, MD
Organizational Affiliation
Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32175985
Citation
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.
Results Reference
derived

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TAPB vs QLBII for Kidney Transplantation Procedure

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