Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty

Knee Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763814
• Other study ID #: Advocate-IRB-5235
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: April 2019

Study information

• Verified date: June 2019
• Source: Chicago Anesthesia Pain Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Chicago Anesthesia Pain Specialists	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Chicago Anesthesia Pain Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the overall satisfaction	At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.	Postoperative
Primary	Change in the Numeric Rating Pain Score	At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.	Postoperative
Secondary	Change in the ability to move the knee	At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.	Postoperative
Secondary	Change in Supplemental pain medications	At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.	Postoperative