Insertion Distance of Interscalene Perineural Catheters in the Context of Shoulder Surgery.

This study is currently recruiting participants.

Verified by Centre hospitalier de l'Université de Montréal (CHUM), September 2008

Sponsored by:	Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT00754026

Purpose

This study is designed to compare interscalene catheter insertion distances, in order to determine which is the best for pain relief after shoulder surgery.

Condition	Intervention
Pain	Procedure: Insertion of interscalene catheter for shoulder surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Influence of the Insertion Distance on Loss of Sensation Produced by Interscalene Perineural Catheters in the Context of Shoulder Surgery.

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:

Sensory block assessment [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of pain relief [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Procedure: Insertion of interscalene catheter for shoulder surgery Distance of interscalene catheter: 2cm
2: Active Comparator	Procedure: Insertion of interscalene catheter for shoulder surgery Distance of interscalene catheter: 6cm

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 18 years and older undergoing elective shoulder surgery

Exclusion Criteria:

Severe COPD
Coagulopathy
Allergy to local anesthetics
Chronic use of opioids
Peripheral neuropathy of the operated limb
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754026

Contacts

Contact: Geneviève Arcand, MD, FRCPC

514-890-8000 ext 26125

g.arcand@gmail.com

Locations

Canada, Quebec
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)	Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Geneviève Arcand, MD, FRCPC 514-890-8000 ext 26125 g.arcand@gmail.com
Contact: Monique M Ruel, RN, CCRP 514-890-8000 ext 24542 monique.m.ruel.chum@ssss.gouv.qc.ca

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Principal Investigator:

Geneviève Arcand, MD, FRCPC

Centre Hospitalier de l'Université de Montréal

More Information

Responsible Party:	Centre Hospitalier de l'Université de Montréal ( Dr Geneviève Arcand )
Study ID Numbers:	08.072
Study First Received:	September 15, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00754026
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):

Shoulder surgery

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 13, 2009