QLB: Quadratus Lumborum Block for Percutaneous Nephrostomy

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02121951

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrostomy; Complications Upper Urinary Tract Dilatation and Obstruction Regional Anesthesia Morbidity Adverse Anesthesia Outcome	Procedure: Local Anesthetic infiltration Procedure: Quadratus Lumborum block Drug: MAC	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

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	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 Drug: MAC Incremental doses are given to the targed sedation and analgesia Other Names: -Midazolam: 1 mg\ml -Fentanyl: 10 mic\ml

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

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

Drug: MAC

Incremental doses are given to the targed sedation and analgesia

Other Names:

-Midazolam: 1 mg\ml

-Fentanyl: 10 mic\ml

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.