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Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080363
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmet Murat Yayik, Ataturk University

Brief Summary:

Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation.

Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream).

The quadratus lumborum block was first described by Blanco. QL block is performed as one of the perioperative pain management procedures for abdominal surgery. QL block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.


Condition or disease Intervention/treatment Phase
Pain, Acute Drug: Bupivacaine Drug: Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Painless ESWL Possible? Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During Extracorporeal Shockwave Lithotripsy
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Quadratus Lumborum Block
Ultrasound guided Quadratus Lumborum Block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine
Drug: Bupivacaine
10 ml %0.5 bupivacaine

Drug: Lidocaine
10 ml %2 lidocaine

No Intervention: Group Control
No intervention



Primary Outcome Measures :
  1. Visual Analog Pain Score [ Time Frame: Intraoperative 30 minutes ]
    Visual Analog Pain Score at 5.,10.,15., 20., 25., 30. minutes


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: Intraoperative 30 minutes ]
    Opioid consumption at 5.,10.,15., 20., 25., 30. minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy

Exclusion Criteria:

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • emergency cases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080363


Locations
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Turkey
Ataturk University
Erzurum, Turkey
Sponsors and Collaborators
Ataturk University
Publications:
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Responsible Party: Ahmet Murat Yayik, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier: NCT03080363    
Other Study ID Numbers: Ataturk University ESWL
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmet Murat Yayik, Ataturk University:
Extracorporeal Shockwave Lithotripsy
Quadratus Lumborum Block
bupivacaine
lidocaine
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action