Quadratus Lumborum Block for Percutaneous Nephrostomy (QLB)

April 8, 2018 updated by: Ghada M N Bashandy, National Cancer Institute, Egypt

Quadratus Lumborum Block Versus Local Anesthetic Infiltration Combined With Monitored Anesthesia Care for Percutaneous Nephrostomy

Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone position.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Quadratus Lumborum block is a novel technique in which extension into the thoracic paravertebral space may occur. QL block would seem to be able to alleviate both somatic and visceral pain so it's expected to decrease the need for systemic sedation\analgesia to a minimum.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Old Cairo
      • Cairo, Old Cairo, Egypt, 11796
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ASA grade III and IV patients,
  2. Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy

Exclusion Criteria:

  1. Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm3.
  2. Untreated urinary tract infection;
  3. Pre-operative haemoglobin <10 gm/dl,
  4. Severely co morbid patients
  5. Non-dilated renal collecting system
  6. Patient refusal to consent for the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Local Anesthetic infiltration and MAC
  • Local Anesthetic infiltration with 1% lignocaine
  • MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml
Procedure: Local Anesthetic infiltration
Lignocaine infiltration through the nephrostomy track
Other Names:
  • Lignocaine
Drug: MAC
Incremental doses are given to the targed sedation and analgesia
Other Names:
  • -Midazolam: 1 mg\ml
  • -Fentanyl: 10 mic\ml
Experimental: Quadratus Lumborum block and MAC
  • QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine
  • MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml
Drug: MAC
Incremental doses are given to the targed sedation and analgesia
Other Names:
  • -Midazolam: 1 mg\ml
  • -Fentanyl: 10 mic\ml
Procedure: Quadratus Lumborum block
A linear 12-MHz ultrasound probe will be placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this point the layers of abdominal layers starte to taper. The probe will be placed in the posterior axillary line, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL will be noticed. At the posterior border of the quadratus lumborum muscle and outside the fascia, Touhe needle will be inserted in plane and confirmed its position by injecting saline. Under ultrasound (US) guidance, local anesthetic mixure will be deposited separating the fascia
Other Names:
  • -0.25% levobupivacaine (Chirocaine, Abbott, Ireland)
  • -1% lignocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia
Time Frame: 4 hours
Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Depression
Time Frame: 4 hours
Respiratory rate and airway patency is monitored with an anesthesiologist.
4 hours
Sedation
Time Frame: 4 hours
Ramsay Seadation Score is assessed during and after procedure till discharge
4 hours
Cardiovascular stability
Time Frame: 4 hours
Blood pressure and Heart rate is assessed during and after procedure till discharge
4 hours
Patient Satisfaction
Time Frame: 48 hours
Patient Satisfaction Quistionaire
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Study Director: Dina N Abbas, M D, National Cancer Institute, Egypt
  • Principal Investigator: Ghada M Bashandy, MD, National Cancer Institute, Egypt
  • Study Chair: Wael Darwish, M D, National Cancer Institute, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 20, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 8, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Quadratus lumborum block

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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