Quadratus Lumborum Block as an Anesthetic Method for Percutaneous Nephrolithotomy

NCT04852874 | Unknown

• 1 other identifier: Uro_Azhar_8_021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate the efficacy and safety of QLB, as an anaesthetic method, for patients undergoing PCNL. Adult patients who agree to participate in the study will be included. Uncooperable patients, pregnant woman, active urinary tract infection, uncorrectable coagulation disorder, and those with known allergy to study medication will be excluded. Low dose spinal anaesthesia and Ultrasound-guided QLB will be performed. The success of the procedure, procedure-related complications, Intra- and post-operative hemodynamics, pain score, overall surgeon and patient satisfaction will be evaluated and reported.

Conditions

Quadratus Lumborum Block; Percutaneous Nephrolithotomy; Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• Success of the QLB

  Accomplishing of the PCNL procedure with no need of alteration to general anesthesia with neutral or more better levels of surgeon and patient satisfaction using a five-point scale of customer Satisfaction survey score of 5 points

  At the end of PCNL procedure.

Secondary Outcomes (11)

• Blood pressure

  Intra-operative

• Pulse

  Intra-operative

• spo2

  Intra-operative

• Visual analogue scale

  Intra-operative, and post-operative at 0,1,2, 4, 8, 12,16,20,24 hours

• Time for the 1st analgesic requirement.

  Intra- and post-operative up to 24 hours

Study Arms (1)

Ultrasound-guided Quadratus Lumborum Block

EXPERIMENTAL

Procedure: Ultrasound-guided Quadratus Lumborum Block

Interventions

Ultrasound-guided Quadratus Lumborum Block PROCEDURE

Low dose spinal anesthesia will be done at L3-4 lumbar vertebrae with bupivacaine 2.5 mg (0.5 ml Marcaine 0.5%) and fentanyl 25 µgm (0.5 ml) of fentanyl amp (100 µgm/ 2ml) to be added to 1.5 - 2 ml of free water to form total volume of 2.5- 3ml according to the patient height aiming level of T6 sensory level. Quadratus lumorum block: After 4 to 5 minutes, ultrasound guided quadratus lumborum block (QL 1,2,3) will be done unilaterally, using low-frequency convex probe, taking into consideration the total volume of injectate not exceeding 0.4 ml /kg of (bupivacaine 0.5%) to avoid local anesthesia systemic toxicity. This is equal to 0.8 ml/kg of (bupivacaine 0.25%). After confirming the correct position of the needle, 0.2-3 ml/kg of 0.25% bupivacaine plus 1.5 mg dexamethasone and magnesium sulphate of 100 mg will be injected in each site of the QL 1,2,3 using the lean body weight. The lean body weight will be calculated by omni lean body mass online calculator.

Ultrasound-guided Quadratus Lumborum Block

Eligibility Criteria

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

You may qualify if:

• Adult patients who will undergo an elective unilateral PCNL and agree to participate in the study will be included

You may not qualify if:

• Uncooperable patients
• Pregnant women
• Untreated urinary tract infection
• Uncorrected coagulation disorder
• Known allergy to study medications
• Local infection at the site of injection.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Urology Department, Al-Azhar University Hospital

Cairo, Egypt

RECRUITING

Central Study Contacts

Abul-fotouh Ahmed, MD

CONTACT

00201001066756; abulfotouhahmed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology and Andrology

Model Details: Prospective, single-arm, open-label, interventional study

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 21, 2021
• Study Start: April 3, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

EG (1)