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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02121951
Other study ID # Quadratus Lumborum Block
Secondary ID
Status Withdrawn
Phase Phase 4
First received April 20, 2014
Last updated April 8, 2018
Start date May 2014
Est. completion date August 2014

Study information

Verified date April 2018
Source National Cancer Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Local Anesthetic infiltration
Lignocaine infiltration through the nephrostomy track
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
Drug:
MAC
Incremental doses are given to the targed sedation and analgesia

Locations

Country Name City State
Egypt National Cancer Institute Cairo Old Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Analgesia Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department. 4 hours
Secondary Respiratory Depression Respiratory rate and airway patency is monitored with an anesthesiologist. 4 hours
Secondary Sedation Ramsay Seadation Score is assessed during and after procedure till discharge 4 hours
Secondary Cardiovascular stability Blood pressure and Heart rate is assessed during and after procedure till discharge 4 hours
Secondary Patient Satisfaction Patient Satisfaction Quistionaire 48 hours
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