Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
104 participants
INTERVENTIONAL
2016-04-08
2017-05-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Quadratus Lumborum Block type II
Local anaesthetic injection on the posterior border of the quadratus lumborum muscle
Bupivacaine
20 ml of bupivacaine with adrenaline
Ultraplex
A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
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
Transversus Abdominalis Plane Block
Local anaesthetic injection between internal oblique and transversus abdominis muscle
Bupivacaine
20 ml of bupivacaine with adrenaline
Ultraplex
A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
Interventions
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Quadratus Lumborum Block type II
Local anaesthetic injection on the posterior border of the quadratus lumborum muscle
Transversus Abdominalis Plane Block
Local anaesthetic injection between internal oblique and transversus abdominis muscle
Bupivacaine
20 ml of bupivacaine with adrenaline
Ultraplex
A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Marcin Kołacz
MD, PhD
Principal Investigators
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Marcin Kolacz, MD,PhD
Role: STUDY_DIRECTOR
Medical University of Warsaw
Marcin Mieszkowski, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland
Locations
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I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Warsaw, , Poland
Countries
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References
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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.
Other Identifiers
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TAPB/QLB-WAW/OLS
Identifier Type: -
Identifier Source: org_study_id
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