A Comparison of Sartorius Vs. Quadriceps Evoked Motor Response for Femoral Nerve to Prevent Secondary Catheter Failure

NCT01313546 | Unknown Early Phase 1

• 1 other identifier: Sunnybrook_Women's
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Continuous nerve block (freezing the nerve) is needed for knee replacement surgery to reduce pain, increase rehabilitation and discharge patients home fast. A lot of time, money and hospital resources are invested in inserting these catheters. The aim of this study is to compare two end points used for insertion of continuous femoral nerve block and to see which one results in fewer failures on the surgical ward. Methodology: Patients having total knee replacement surgery will be recruited in this study. Patients will be randomized into two groups. The continuous femoral nerve block catheter will be inserted using ultrasound and nerve stimulation with two different end points (certain muscle contraction). Patients will be followed on day 1 and 2 after surgery to observe which catheter fails, how much pain the patient suffers and how much painkiller the patients used.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Femoral nerve block; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• the number of secondary catheter failures

  to prevent the occurance of failed femoral nerve catheter on postoperative day 1

  12 months

Secondary Outcomes (1)

• total morphine consumption

  12 months

Study Arms (2)

quadriceps

ACTIVE COMPARATOR

quadriceps muscular contraction

Other: Stimulation of quariceps muscle

sartorius

ACTIVE COMPARATOR

stimulation of sartorius muscle through femoral nerve

Other: Stimulation of quariceps muscle

Interventions

Stimulation of quariceps muscle OTHER

stimulation of quadriceps muscle through the stimulating catheter

Also known as: Medial stimulation, patellar twitches

quadriceps; sartorius

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having total knee arthroplasty AsA 1-3

You may not qualify if:

• patients with a history of significant medical or psychiatric problems, BMI \> 40, allergy to local anesthetic drugs, prior surgery in the inguinal region, neurological disease with sensory or motor deficit, and diabetic neuropathy.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

The Holland orthopedic and arthritic centre

Toronto, Ontario, Canada

Location

Study Officials

• imad Awad, FFARCSI

  Sunnybrook Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMAD AWAD, MBChB

CONTACT

416 480 4864; imad.awad@sunnybrook.ca

colin MCCARTNEY, FRCPC

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 11, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 11, 2011

Record last verified: 2011-03

Locations

CA (1)