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

Ultrasound-guided Continuous Quadratus Lumborum Block III for Postoperative Analgesia in Percutaneous Nephrolithotomy

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Surgery; Renal Stone
• Intervention / Treatment: Procedure: Continous Quadratum Lumborum Block III; Procedure: Single dose Quadratum Lumborum Block III; Procedure: Intra-venous Morphine

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption.	Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.	24 hours

Collaborators and Investigators

• Sponsor: Nazmy Edward Seif
• Investigators: Principal Investigator: Sherif A Embaby, MSc, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): June 28, 2022
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Analgesia; Ultrasound-guided; Percutaneous nephrolithotomy; Quadratus Lumborum Block III
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: USGCQLBIIIPCNL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No