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

Sponsor

Nazmy Edward Seif (Other)

Overall Status

Completed

CT.gov ID

NCT04800302

Collaborator

(none)

Enrollment

Location

Arms

12.6

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

Actual 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 :

Jun 10, 2021

Actual Primary Completion Date :

Jun 28, 2022

Actual Study Completion Date :

Jun 28, 2022

Arms and Interventions

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.

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

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

Primary Outcome Measures

Morphine consumption. [24 hours]
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Nazmy Edward Seif

Investigators

Principal Investigator: Sherif A Embaby, MSc, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nazmy Edward Seif, Clinical Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04800302

Other Study ID Numbers:

USGCQLBIIIPCNL

First Posted:

Mar 16, 2021

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nazmy Edward Seif, Clinical Professor, Cairo University

Quadratus Lumborum Block III

Ultrasound-guided

Percutaneous nephrolithotomy

Analgesia

Additional relevant MeSH terms:

Kidney Calculi

Nephrolithiasis

Morphine

Study Results

No Results Posted as of Jul 22, 2022