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Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

Primary Purpose

Kidney Stone

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine TQL block
Saline TQL block
Ropivacaine
Saline
Ultrasound
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring Postoperative pain, Transmuscular quadratus lumborum block, Block, Ropivacaine, TQL, percutaneous nephrolithotomy, PNL, Ultrasound-guided

Eligibility Criteria

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

Inclusion Criteria:

Scheduled for elective PNL operation in general anaesthesia with propofol and remifentanil.

Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3

Exclusion Criteria:

Cannot cooperate Does not speak or understand Danish Allergy towards drugs used in the trial Large daily consumption of opioids Known alcohol or drug abuse Difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the USG-TQL block Pregnancy

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Ropivacaine TQL block

    Placebo TQL block

    Arm Description

    Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%

    Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9%

    Outcomes

    Primary Outcome Measures

    Total morphine consumption
    Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record

    Secondary Outcome Measures

    Total morphine consumption
    Data from PCA pump and patient electronic file
    Pain score at rest (NRS 0-10/10)
    Pain score NRS
    Pain score at sitting position (NRS 0-10/10)
    Pain score NRS
    Time to first ambulation - get out of bed
    Time to first ambulation from bed to walk on the floor
    Opioid side effects (nausea, vomiting)
    PONV, number of episodes, antiemetics
    NRS score during application of the TQL block (NRS 0-10/10)
    Procedure discomfort

    Full Information

    First Posted
    June 27, 2016
    Last Updated
    March 21, 2018
    Sponsor
    Zealand University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02818140
    Brief Title
    Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy
    Official Title
    Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Percutaneous Nephrolithotomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    March 2018 (Actual)
    Study Completion Date
    March 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zealand University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime. 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.
    Detailed Description
    Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime, and the patients receive considerable amounts of long lasting opioids. For the patients this greatly increase the risk of experiencing the adverse effects of opioids. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Stone
    Keywords
    Postoperative pain, Transmuscular quadratus lumborum block, Block, Ropivacaine, TQL, percutaneous nephrolithotomy, PNL, Ultrasound-guided

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Ropivacaine TQL block
    Arm Type
    Active Comparator
    Arm Description
    Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%
    Arm Title
    Placebo TQL block
    Arm Type
    Placebo Comparator
    Arm Description
    Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9%
    Intervention Type
    Procedure
    Intervention Name(s)
    Ropivacaine TQL block
    Other Intervention Name(s)
    Naropin
    Intervention Description
    Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Saline TQL block
    Intervention Description
    Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Primary Outcome Measure Information:
    Title
    Total morphine consumption
    Description
    Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record
    Time Frame
    6 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Total morphine consumption
    Description
    Data from PCA pump and patient electronic file
    Time Frame
    15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively
    Title
    Pain score at rest (NRS 0-10/10)
    Description
    Pain score NRS
    Time Frame
    15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively
    Title
    Pain score at sitting position (NRS 0-10/10)
    Description
    Pain score NRS
    Time Frame
    15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively
    Title
    Time to first ambulation - get out of bed
    Description
    Time to first ambulation from bed to walk on the floor
    Time Frame
    0-24 hours postoperatively
    Title
    Opioid side effects (nausea, vomiting)
    Description
    PONV, number of episodes, antiemetics
    Time Frame
    0-24 hours postoperatively
    Title
    NRS score during application of the TQL block (NRS 0-10/10)
    Description
    Procedure discomfort
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Scheduled for elective PNL operation in general anaesthesia with propofol and remifentanil. Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3 Exclusion Criteria: Cannot cooperate Does not speak or understand Danish Allergy towards drugs used in the trial Large daily consumption of opioids Known alcohol or drug abuse Difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the USG-TQL block Pregnancy -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mette Dam, MD, PhD Fellow
    Organizational Affiliation
    Zealand University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26771297
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27072772
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31153628
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

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