Quadratus Lumborum Block for Percutaneous Nephrostomy

NCT02121951 | Withdrawn Phase 4 DMC

• 1 other identifier: Quadratus Lumborum Block
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Percutaneous Nephrostomy; Quadtatus Lumborum Block; Cancer; Monitored Anaesthesia Care

Outcome Measures

Primary Outcomes (1)

• Analgesia

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

  4 hours

Secondary Outcomes (4)

• Respiratory Depression

  4 hours

• Sedation

  4 hours

• Cardiovascular stability

  4 hours

• Patient Satisfaction

  48 hours

Study Arms (2)

Local Anesthetic infiltration and MAC

ACTIVE COMPARATOR

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

Procedure: Local Anesthetic infiltration; Drug: MAC

Quadratus Lumborum block and MAC

EXPERIMENTAL

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

Procedure: Quadratus Lumborum block; Drug: MAC

Interventions

Local Anesthetic infiltration PROCEDURE

Lignocaine infiltration through the nephrostomy track

Also known as: Lignocaine

Local Anesthetic infiltration and MAC

Quadratus Lumborum block PROCEDURE

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

Also known as: -0.25% levobupivacaine (Chirocaine, Abbott, Ireland), -1% lignocaine

Quadratus Lumborum block and MAC

MAC DRUG

Incremental doses are given to the targed sedation and analgesia

Also known as: -Midazolam: 1 mg\ml, -Fentanyl: 10 mic\ml

Local Anesthetic infiltration and MAC; Quadratus Lumborum block and MAC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Old Cairo, 11796, Egypt

Location

Related Publications (2)

• 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.

  PMID: 24249997 RESULT

• 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.

  PMID: 24310051 RESULT

MeSH Terms

Conditions

Bites and Stings; Neoplasms

Interventions

Lidocaine; Levobupivacaine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bupivacaine

Study Officials

• Dina N Abbas, M D

  National Cancer Institute, Egypt

  STUDY DIRECTOR

• Ghada M Bashandy, MD

  National Cancer Institute, Egypt

  PRINCIPAL INVESTIGATOR

• Wael Darwish, M D

  National Cancer Institute, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 20, 2014
• First Posted: April 24, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

EG (1)