NCT00726219

Brief Summary

This study is designed to compare femoral perineural catheter insertion distances, in order to help determine which is the best for pain relief after knee surgery. Hypothesis: the quality of the femoral nerve block will not be inferior if the catheter is inserted deeper (7cm compared to 3 cm)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 10, 2011

Status Verified

June 1, 2010

Enrollment Period

11 months

First QC Date

July 29, 2008

Last Update Submit

February 9, 2011

Conditions

Total Knee Arthroplasty

Keywords

Majorkneesurgery

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

OTHER

Insertion distance of femoral catheter: 3cm

Other: Femoral perineural catheter

2

OTHER

Insertion distance of femoral catheter: 7cm

Other: Femoral perineural catheter

Interventions

Femoral perineural catheterOTHER

Comparison of 2 insertion distances (3 vs 7 cm) for a femoral perineural catheter in the context of major knee surgery.

12

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 years or older undergoing major knee surgery.

You may not qualify if:

  • Coagulopathy
  • Pregnancy
  • Allergy to local anesthetics
  • Patient unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CSSS Chicoutimi

Chicoutimi, Quebec, G7H 5H6, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

Study Officials

  • Stephan R Williams, MD, PhD

    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

July 29, 2008

First Posted

July 31, 2008

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

February 10, 2011

Record last verified: 2010-06

Locations

CA(2)