Overview

This trial is active, not recruiting.

Condition knee arthroplasty
Treatments femoral nerve block, femoral nerve block non stimulating catheter, femoral nerve block stimulating catheter
Sponsor Chicago Anesthesia Pain Specialists
Start date December 2011
End date December 2016
Trial size 120 participants
Trial identifier NCT01763814, Advocate-IRB-5235

Summary

Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Active Comparator)
A ultrasound probe will be used to identify the nerve, and correct needle placement.
femoral nerve block
A visible or palpable cephalad movement of the patella will confirm needle placement.
(Active Comparator)
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off.
femoral nerve block
A visible or palpable cephalad movement of the patella will confirm needle placement.
femoral nerve block non stimulating catheter
A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.
(Active Comparator)
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on.
femoral nerve block
A visible or palpable cephalad movement of the patella will confirm needle placement.
femoral nerve block stimulating catheter
A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.

Primary Outcomes

Measure
Change in the Numeric Rating Pain Score
time frame: Postoperative

Secondary Outcomes

Measure
Change in the ability to move the knee
time frame: Postoperative
Change in Supplemental pain medications
time frame: Postoperative

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - 18- 90 years old - Scheduled for total knee arthroplasty Exclusion Criteria: - Redo surgery on the same knee - BMI ≥45 - Radicular pain in the same leg - Allergy to local anesthetics - Opioid habituation - Pregnancy - Contraindication to regional block - Inability to communicate with hospital staff or investigators. - Neuropathy of any etiology in the surgical extremity.

Additional Information

Official title A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
Principal investigator Antony Tharian, M.D.
Description This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups: Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Chicago Anesthesia Pain Specialists.