Ultrasound Guided Femoral Nerve Block and Ultrasound Guided Femoral Nerve Block With Peripheral Nerve Stimulation in Knee Replacement Surgery

Total Knee Replacement Surgery Clinical Trial

Official title:

Comparison Between Ultrasound Guided Femoral Nerve Block Versus Ultrasound Guided Femoral Nerve Block With the Use of Peripheral Nerve Stimulation for Patients Undergoing Total Knee Replacement.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00927368
• Other study ID #: 09-340
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2009
• Last updated: December 18, 2013
• Start date: July 2009
• Est. completion date: May 2014

Study information

• Verified date: January 2013
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.

Description:

This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.

• Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10.

• Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed.

• Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery.

• Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 to 80 years old at time of surgery.

• Male or female patients undergoing total knee replacement under either general or neuroaxial anesthesia (spinal or epidural). Intraoperative, patients will receive spinal anesthetics with 15 mg bupivacaine and 25mcg of fentanyl intrathecally.

Exclusion Criteria:

• Current or recent drug abuse (within past 6 months).

• Pregnancy.

• Patient refuses regional analgesia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Total Knee Replacement Surgery

Intervention

Procedure:
• stimulation needle and stimulating catheter
ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter
• nerve catheter with stimulating needle
Ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter
• guided femoral nerve block without stimulation
ultrasound guided femoral nerve block without stimulation.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catheter insertion technique comparison	To compare the secondary failure of the femoral nerve catheter inserted by three different technique using ultrasound guided placement of nerve catheters. Secondary failure of the catheter is measured jointly by both pain scores and opioid requirements.	4 years	No
Secondary	pain assessment	Block performance time, block failure rate, number of sciatic nerve blocks, and cost of the femoral nerve blockade procedures	4 years	No