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Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03571490
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.

Condition or disease Intervention/treatment Phase
Postoperative Pain Ultrasound Guided Transmuscular Quadratus Lumborum Block Drug: Ropivacaine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Double blind placebo Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: TQL Ropivacaine(active)
Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine
Drug: Ropivacaine
Single shot of ropivacaine 0.325%

Placebo Comparator: TQL saline (placebo)
Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9%
Drug: Saline
Single shot of saline 0.9%




Primary Outcome Measures :
  1. opioid consumption [ Time Frame: 12 hours postoperatively ]
    Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).


Secondary Outcome Measures :
  1. opioid consumption [ Time Frame: 6 hours postoperatively ]
    Opioid consumption postoperatively (data from PCA pump and patient medical record).

  2. opioid consumption [ Time Frame: 18 hours postoperatively ]
    Opioid consumption postoperatively (data from PCA pump and patient medical record).

  3. opioid consumption [ Time Frame: 24 hours postoperatively ]
    Opioid consumption postoperatively (data from PCA pump and patient medical record).

  4. NRS score [ Time Frame: 12 hours postoperatively ]
    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity

  5. NRS score at rest and activity [ Time Frame: 6 hours postoperatively ]
    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  6. NRS score at rest and activity [ Time Frame: 18 hours postoperatively ]
    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  7. NRS score at rest and activity [ Time Frame: 24 hours postoperatively ]
    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  8. Opioid-related side effects [ Time Frame: 6 hours postoperatively ]
    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  9. Opioid-related side effects [ Time Frame: 12 hours postoperatively ]
    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  10. Opioid-related side effects [ Time Frame: 18 hours postoperatively ]
    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  11. Opioid-related side effects [ Time Frame: 24 hours postoperatively ]
    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  12. Patient satisfaction with application of the block. NRS [ Time Frame: Immediately after application of the block ]
    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  13. Ambulation [ Time Frame: within 24 hours postoperatively ]
    Time from operation to ambulation



Information from the National Library of Medicine

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

Inclusion Criteria:

  • over 18 years
  • Kidney cancer
  • Have received thorough information, orally and in written
  • Signed the "Informed Consent" form on participation in the trial

Exclusion Criteria:

  • Inability to cooperate
  • Inability to speak and understand Danish both orally and written
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids
  • Local infection at the site of injection or systemic infection
  • Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
  • Known abuse of alcohol or medicine
  • Pregnancy

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): NCT03571490


Locations
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Denmark
Zealand university Hospital, Anaesthesiology Recruiting
Roskilde, Denmark, 4000
Contact: Jens Børglum, Phd    +45 30700120    jedn@regionsjaelland.dk   
Principal Investigator: Mette Dam, Phd Student         
Sub-Investigator: Christian Hansen, Phd Student         
Sub-Investigator: martin Vedel, Phd Student         
Sub-Investigator: Katrine Tangaard, Phd Student         
Sponsors and Collaborators
Zealand University Hospital

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03571490    
Other Study ID Numbers: V2.02.05.2017
2017-002130-23 ( EudraCT Number )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents