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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04800302
Other study ID # USGCQLBIIIPCNL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2021
Est. completion date June 28, 2022

Study information

Verified date July 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date June 28, 2022
Est. primary completion date June 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Cairo University Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphine consumption. Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively. 24 hours
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