NCT00754026

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 28, 2010

Status Verified

May 1, 2010

Enrollment Period

1.7 years

First QC Date

September 15, 2008

Last Update Submit

May 27, 2010

Conditions

Pain

Keywords

Shoulder surgery

Outcome Measures

Primary Outcomes (1)

  • Sensory block assessment

    24 hours after surgery

Secondary Outcomes (1)

  • Quality of pain relief

    24 hours after surgery

Study Arms (2)

1

ACTIVE COMPARATOR
Procedure: Insertion of interscalene catheter for shoulder surgery

2

ACTIVE COMPARATOR
Procedure: Insertion of interscalene catheter for shoulder surgery

Interventions

Insertion of interscalene catheter for shoulder surgeryPROCEDURE

Distance of interscalene catheter: 2cm

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years and older undergoing elective shoulder surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Geneviève Arcand, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 17, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 28, 2010

Record last verified: 2010-05

Locations

CA(1)