Quadratus Lumborum Block for Percutaneous Nephrostomy

NCT ID: NCT02121951

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Local Anesthetic infiltration and MAC

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

Group Type: ACTIVE_COMPARATOR

Local Anesthetic infiltration

Intervention Type: PROCEDURE

Lignocaine infiltration through the nephrostomy track

MAC

Intervention Type: DRUG

Incremental doses are given to the targed sedation and analgesia

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

Group Type: EXPERIMENTAL

Quadratus Lumborum block

Intervention Type: 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

MAC

Intervention Type: DRUG

Incremental doses are given to the targed sedation and analgesia

Interventions

Local Anesthetic infiltration

Lignocaine infiltration through the nephrostomy track

Intervention Type: 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

Intervention Type: PROCEDURE

MAC

Incremental doses are given to the targed sedation and analgesia

Intervention Type: DRUG

Other Intervention Names

Lignocaine; -0.25% levobupivacaine (Chirocaine, Abbott, Ireland); -1% lignocaine; -Midazolam: 1 mg\ml; -Fentanyl: 10 mic\ml

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ghada M N Bashandy

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina N Abbas, M D

Role: STUDY_DIRECTOR

National Cancer Institute, Egypt

Ghada M Bashandy, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Egypt

Wael Darwish, M D

Role: STUDY_CHAIR

National Cancer Institute, Egypt

Locations

National Cancer Institute

Cairo, Old Cairo, Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 24249997 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24310051 (View on PubMed)

Other Identifiers

Quadratus Lumborum Block

Identifier Type: -

Identifier Source: org_study_id