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CompletedNCT04800302Updated Jul 22, 2022

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

An interventional study of Continous Quadratum Lumborum Block III and Single dose Quadratum Lumborum Block III in Analgesia, Surgery and Renal Stone, sponsored by Nazmy Edward Seif. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by Nazmy Edward Seif · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Analgesia
  • Surgery
  • Renal Stone

Keywords

  • Quadratus Lumborum Block III
  • Ultrasound-guided
  • Percutaneous nephrolithotomy
  • Analgesia
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's enrollment of 45 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.

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Lead sponsor

Nazmy Edward Seif is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Continuous QLB group

    U/S-guided continous QLB III

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

  • Active comparator
    Single dose QLB group

    U/S-guided single dose QLB III

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

  • Active comparator
    Morphine group

    IV Morphine

    Procedure: Intra-venous Morphine

Interventions

  • ProcedureContinous 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.

  • ProcedureSingle 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.

  • ProcedureIntra-venous Morphine

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

06

What researchers measure

Primary outcomes

  1. Morphine consumption.

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

    Time frame: 24 hours

07

Study locations

1 site
  • Cairo University Hospitals
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04800302
Lead sponsor
Nazmy Edward Seif
Responsible party
Nazmy Edward Seif (Clinical Professor, Cairo University) — Sponsor-investigator
First posted
Mar 16, 2021
Start date
Jun 10, 2021
Primary completion
Jun 28, 2022
Completion
Jun 28, 2022
Last update
Jul 22, 2022

Study contacts

Sherif A Embaby, MSc
principal investigator · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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