Back to resultsU/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy
Primary Purpose
Analgesia, Surgery, Renal Stone
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Continous Quadratum Lumborum Block III
Single dose Quadratum Lumborum Block III
Intra-venous Morphine
Sponsored by
About this trial
This is an interventional supportive care trial for Analgesia focused on measuring Quadratus Lumborum Block III, Ultrasound-guided, Percutaneous nephrolithotomy, Analgesia
Eligibility 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.
Sites / Locations
- Cairo University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Continuous QLB group
Single dose QLB group
Morphine group
Arm Description
U/S-guided continous QLB III
U/S-guided single dose QLB III
IV Morphine
Outcomes
Primary Outcome Measures
Morphine consumption.
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04800302
Brief Title
U/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy
Official Title
Ultrasound-guided Continuous Quadratus Lumborum Block III for Postoperative Analgesia in Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazmy Edward Seif
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Surgery, Renal Stone
Keywords
Quadratus Lumborum Block III, Ultrasound-guided, Percutaneous nephrolithotomy, Analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous QLB group
Arm Type
Experimental
Arm Description
U/S-guided continous QLB III
Arm Title
Single dose QLB group
Arm Type
Active Comparator
Arm Description
U/S-guided single dose QLB III
Arm Title
Morphine group
Arm Type
Active Comparator
Arm Description
IV Morphine
Intervention Type
Procedure
Intervention Name(s)
Continous Quadratum Lumborum Block III
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single dose Quadratum Lumborum Block III
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intra-venous Morphine
Intervention Description
Intra-venous Morphine [0.1 mg/kg] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.
Primary Outcome Measure Information:
Title
Morphine consumption.
Description
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif A Embaby, MSc
Organizational Affiliation
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
U/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy
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