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

NCT ID: NCT04800302

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2022-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Analgesia Surgery Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Continuous QLB group

U/S-guided continous QLB III

Group Type EXPERIMENTAL

Continous Quadratum Lumborum Block III

Intervention Type 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.

Single dose Quadratum Lumborum Block III

Intervention Type 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.

Intra-venous Morphine

Intervention Type PROCEDURE

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

Single dose QLB group

U/S-guided single dose QLB III

Group Type ACTIVE_COMPARATOR

Single dose Quadratum Lumborum Block III

Intervention Type 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.

Intra-venous Morphine

Intervention Type PROCEDURE

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

Morphine group

IV Morphine

Group Type ACTIVE_COMPARATOR

Intra-venous Morphine

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nazmy Edward Seif

OTHER

Sponsor Role lead

Responsible Party

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Nazmy Edward Seif

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sherif A Embaby, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Cairo University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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USGCQLBIIIPCNL

Identifier Type: -

Identifier Source: org_study_id

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