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

NCT04800302 | Completed

• 1 other identifier: USGCQLBIIIPCNL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Surgery; Renal Stone

Keywords

Quadratus Lumborum Block III; Ultrasound-guided; Percutaneous nephrolithotomy; Analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine consumption.

  Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.

  24 hours

Study Arms (3)

Continuous QLB group

EXPERIMENTAL

U/S-guided continous QLB III

Procedure: Continous Quadratum Lumborum Block III; Procedure: Single dose Quadratum Lumborum Block III; Procedure: Intra-venous Morphine

Single dose QLB group

ACTIVE COMPARATOR

U/S-guided single dose QLB III

Procedure: Single dose Quadratum Lumborum Block III; Procedure: Intra-venous Morphine

Morphine group

ACTIVE COMPARATOR

IV Morphine

Procedure: Intra-venous Morphine

Interventions

Continous Quadratum Lumborum Block III PROCEDURE

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.

Continuous QLB group

Single dose Quadratum Lumborum Block III PROCEDURE

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.

Continuous QLB group; Single dose QLB group

Intra-venous Morphine PROCEDURE

Intra-venous Morphine \[0.1 mg/kg\] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.

Continuous QLB group; Morphine group; Single dose QLB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia; Nephrolithiasis

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Sherif A Embaby, MSc

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: June 10, 2021
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

EG (1)