Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy
NCT ID: NCT02818140
Last Updated: 2018-03-22
Study Results
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Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2016-07-31
2018-03-31
Brief Summary
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We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will significantly reduce postoperative opioid consumption and pain following PNL operation compared with placebo (saline) TQL block.
The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo TQL block) in a randomized and placebo controlled design.
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Detailed Description
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The ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block is a single dosage of local anesthetic (LA) delivered in the plane between the psoas major muscle and the quadratus lumborum muscle. LA spreads cephalad into the thoracic paravertebral space to reach the somatic ventral rami (intercostal nerves) and the thoracic sympathetic trunk. The TQL block can reduce visceral pain and pain originating from the abdominal wall and has an expected duration of analgesic efficacy of 24 hours.
The aim of this study is to investigate the efficacy of the active USG TQL block together with the multimodal analgesic regime to reduce postoperative opioid consumption and pain compared to placebo USG TQL block and the multimodal analgesic regime in a randomized and placebo controlled design.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ropivacaine TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%
Ropivacaine TQL block
Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure
Ropivacaine
Ultrasound
Placebo TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9%
Saline TQL block
Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure
Saline
Ultrasound
Interventions
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Ropivacaine TQL block
Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure
Saline TQL block
Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure
Ropivacaine
Saline
Ultrasound
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3
Exclusion Criteria
\-
18 Years
ALL
No
Sponsors
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Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mette Dam, MD, PhD Fellow
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
References
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Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.
Dam M, Hansen CK, Borglum J, Chan V, Bendtsen TF. A transverse oblique approach to the transmuscular Quadratus Lumborum block. Anaesthesia. 2016 May;71(5):603-4. doi: 10.1111/anae.13453. No abstract available.
Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. doi: 10.1016/j.bja.2019.04.054. Epub 2019 May 30.
Other Identifiers
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2015-004770-16
Identifier Type: -
Identifier Source: org_study_id
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