Overview

This trial is active, not recruiting.

Condition total knee replacement surgery
Treatments stimulation needle and stimulating catheter, nerve catheter with stimulating needle, guided femoral nerve block without stimulation
Sponsor The Cleveland Clinic
Start date July 2009
End date December 2013
Trial size 420 participants
Trial identifier NCT00927368, 09-340

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
ultrasound guided femoral nerve catheter using a stimulation needle and a stimulating catheter
stimulation needle and stimulating catheter
ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter
(Active Comparator)
ultrasound guided femoral nerve catheter using a stimulation needle but non stimulating catheter
nerve catheter with stimulating needle
Ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter
(Active Comparator)
ultrasound guided femoral nerve block without stimulation
guided femoral nerve block without stimulation
ultrasound guided femoral nerve block without stimulation.

Primary Outcomes

Measure
catheter insertion technique comparison
time frame: 4 years

Secondary Outcomes

Measure
pain assessment
time frame: 4 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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.
Principal investigator Ehab Farag, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.