Quadratus Lumborum Block for Percutaneous Nephrostomy

Phase 4

Withdrawn

• Conditions: Nephrostomy; Complications; Regional Anesthesia Morbidity; Upper Urinary Tract Dilatation and Obstruction; Adverse Anesthesia Outcome
• Interventions: Procedure: Local Anesthetic infiltration; Procedure: Quadratus Lumborum block; Drug: MAC

• Registration Number: NCT02121951
• Lead Sponsor: National Cancer Institute, Egypt

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.

Study Timeline

• Study First Submitted: 2014-04-20
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-24
• Study Start: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-08
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anesthetic infiltration and MAC	MAC	* Local Anesthetic infiltration with 1% lignocaine * MAC with IV Midazolam Img\\ml and Fentanyl 10 mic\\ml
Quadratus Lumborum block and MAC	MAC	* QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine * MAC with IV Midazolam Img\\ml and Fentanyl 10 mic\\ml
Local Anesthetic infiltration and MAC	Local Anesthetic infiltration	* Local Anesthetic infiltration with 1% lignocaine * MAC with IV Midazolam Img\\ml and Fentanyl 10 mic\\ml
Quadratus Lumborum block and MAC	Quadratus Lumborum block	* QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine * MAC with IV Midazolam Img\\ml and Fentanyl 10 mic\\ml

Primary Outcome Measures

Name	Time	Method
Analgesia	4 hours	Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Old Cairo, Egypt