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U/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy

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: NCT04800302
Recruitment Status : Active, not recruiting
First Posted : March 16, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Nazmy Edward Seif, Cairo University

Study Description
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Brief Summary:
Percutaneous nephrolithotomy (PCNL) is considered to be the first choice and a more conservative procedure than open stone surgery. Not only postoperative pain related to dilatation of the renal capsule and parenchymal tract, but also patient's discomfort & nephrostomy tube-related stress are reported to delay recovery time and increase the complication rates. This study is designed to provide postoperative analgesia by using ultrasound-guided continuous Quadratus Lumborum Block (QLB) III in patients undergoing PCNL and to assess pain scores & side effects with less opioids consumption.

Condition or disease Intervention/treatment Phase
Analgesia Surgery Renal Stone Procedure: Continous Quadratum Lumborum Block III Procedure: Single dose Quadratum Lumborum Block III Procedure: Intra-venous Morphine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ultrasound-guided Continuous Quadratus Lumborum Block III for Postoperative Analgesia in Percutaneous Nephrolithotomy
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Continuous QLB group
U/S-guided continous QLB III
 Procedure: Continous Quadratum Lumborum Block III
Continuous infusion of Bupivacaine 0.125 % at a rate of 0.1 ml/kg/hr (not exceeding 12 ml/hour), infused through a catheter inserted in the plane between quadratus lumborum & psoas major muscles with ultrasound guidance.

Procedure: Single dose Quadratum Lumborum Block III
Single injection of a mixture solution of 20 ml Bupivacaine 0.5% + 10 ml Lidocaine 2%, injected through a needle inserted at the posterior aspect of the quadratus lumborum muscle between it and erector spinae muscle with ultrasound guidance.

Procedure: Intra-venous Morphine
Intra-venous Morphine [0.1 mg/kg] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.
Active Comparator: Single dose QLB group
U/S-guided single dose QLB III
 Procedure: Single dose Quadratum Lumborum Block III
Single injection of a mixture solution of 20 ml Bupivacaine 0.5% + 10 ml Lidocaine 2%, injected through a needle inserted at the posterior aspect of the quadratus lumborum muscle between it and erector spinae muscle with ultrasound guidance.

Procedure: Intra-venous Morphine
Intra-venous Morphine [0.1 mg/kg] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.
Active Comparator: Morphine group
IV Morphine
 Procedure: Intra-venous Morphine
Intra-venous Morphine [0.1 mg/kg] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.


Outcome Measures
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Primary Outcome Measures :
  1. Morphine consumption. [ Time Frame: 24 hours ]
    Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.


Eligibility Criteria
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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:

  • ASA I-II.
  • Scheduled for percutaneous nephrolithotomy (PCNL).

Exclusion Criteria:

  • Patient refusal.
  • Coagulation disorders.
  • Skin lesions or infection at site of needle insertion.
  • Known allergy to local anesthetics or opioids.
  • Patients suffering from neurological or mental disease.
  • Procedure turned into open stone surgery.
  • Failure of identification by U/S.
  • Urinary tract malignancies.
  • Opioid consumption 48 hours before the operation.
Contacts and Locations
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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): NCT04800302


Locations
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Egypt
Cairo University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Nazmy Edward Seif
Investigators
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Principal Investigator: Sherif A Embaby, MSc Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
More Information
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Responsible Party: Nazmy Edward Seif, Clinical Professor, Cairo University
ClinicalTrials.gov Identifier: NCT04800302    
Other Study ID Numbers: USGCQLBIIIPCNL
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
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 Nazmy Edward Seif, Cairo University:
Quadratus Lumborum Block III
Ultrasound-guided
Percutaneous nephrolithotomy
Analgesia
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
 Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents