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

This study has been completed.
Sponsor:
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00754026
First received: September 15, 2008
Last updated: May 27, 2010
Last verified: May 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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 ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Insertion of interscalene catheter for shoulder surgery
Distance of interscalene catheter: 2cm
Active Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, Canada, H2L 4M1
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

No publications provided

Responsible Party: Dr Geneviève Arcand, Centre Hospitalier de l'Université de Montréal
ClinicalTrials.gov Identifier: NCT00754026     History of Changes
Other Study ID Numbers: 08.072
Study First Received: September 15, 2008
Last Updated: May 27, 2010
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on November 27, 2014