search
Back to results

Quadratus Lumborum Block for Percutaneous Nephrostomy (QLB)

Primary Purpose

Nephrostomy; Complications, Upper Urinary Tract Dilatation and Obstruction, Regional Anesthesia Morbidity

Status
Withdrawn
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Local Anesthetic infiltration
Quadratus Lumborum block
MAC
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrostomy; Complications focused on measuring Percutaneous Nephrostomy, Quadtatus Lumborum Block, Cancer, Monitored Anaesthesia Care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Local Anesthetic infiltration and MAC

Quadratus Lumborum block and MAC

Arm Description

Local Anesthetic infiltration with 1% lignocaine MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml

QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml

Outcomes

Primary Outcome Measures

Analgesia
Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.

Secondary Outcome Measures

Respiratory Depression
Respiratory rate and airway patency is monitored with an anesthesiologist.
Sedation
Ramsay Seadation Score is assessed during and after procedure till discharge
Cardiovascular stability
Blood pressure and Heart rate is assessed during and after procedure till discharge
Patient Satisfaction
Patient Satisfaction Quistionaire

Full Information

First Posted
April 20, 2014
Last Updated
April 8, 2018
Sponsor
National Cancer Institute, Egypt
search

1. Study Identification

Unique Protocol Identification Number
NCT02121951
Brief Title
Quadratus Lumborum Block for Percutaneous Nephrostomy
Acronym
QLB
Official Title
Quadratus Lumborum Block Versus Local Anesthetic Infiltration Combined With Monitored Anesthesia Care for Percutaneous Nephrostomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrostomy; Complications, Upper Urinary Tract Dilatation and Obstruction, Regional Anesthesia Morbidity, Adverse Anesthesia Outcome
Keywords
Percutaneous Nephrostomy, Quadtatus Lumborum Block, Cancer, Monitored Anaesthesia Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local Anesthetic infiltration and MAC
Arm Type
Active Comparator
Arm Description
Local Anesthetic infiltration with 1% lignocaine MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml
Arm Title
Quadratus Lumborum block and MAC
Arm Type
Experimental
Arm Description
QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml
Intervention Type
Procedure
Intervention Name(s)
Local Anesthetic infiltration
Other Intervention Name(s)
Lignocaine
Intervention Description
Lignocaine infiltration through the nephrostomy track
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum block
Other Intervention Name(s)
-0.25% levobupivacaine (Chirocaine, Abbott, Ireland), -1% lignocaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MAC
Other Intervention Name(s)
-Midazolam: 1 mg\ml, -Fentanyl: 10 mic\ml
Intervention Description
Incremental doses are given to the targed sedation and analgesia
Primary Outcome Measure Information:
Title
Analgesia
Description
Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Respiratory Depression
Description
Respiratory rate and airway patency is monitored with an anesthesiologist.
Time Frame
4 hours
Title
Sedation
Description
Ramsay Seadation Score is assessed during and after procedure till discharge
Time Frame
4 hours
Title
Cardiovascular stability
Description
Blood pressure and Heart rate is assessed during and after procedure till discharge
Time Frame
4 hours
Title
Patient Satisfaction
Description
Patient Satisfaction Quistionaire
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA grade III and IV patients, Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy Exclusion Criteria: Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm3. Untreated urinary tract infection; Pre-operative haemoglobin <10 gm/dl, Severely co morbid patients Non-dilated renal collecting system Patient refusal to consent for the procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina N Abbas, M D
Organizational Affiliation
National Cancer Institute, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ghada M Bashandy, MD
Organizational Affiliation
National Cancer Institute, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wael Darwish, M D
Organizational Affiliation
National Cancer Institute, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
State/Province
Old Cairo
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
24249997
Citation
Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
Results Reference
result
PubMed Identifier
24310051
Citation
Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.
Results Reference
result

Learn more about this trial

Quadratus Lumborum Block for Percutaneous Nephrostomy

We'll reach out to this number within 24 hrs