Clinical trial NCT00927368: Comparison of 3 Techniques for Ultrasound-guided Femoral Nerve Catheter Insertion
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement Surgery
Keywords: TKA
total knee replacement
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old at time of surgery.
* Male or female patients undergoing total knee replacement under either general or neuraxial 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.

Primary outcomes:
measure: Time Weighted Average Verbal Response Scale Pain Score
timeFrame: 48 hours after surgery
measure: Opioid Consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Block Performance Time
timeFrame: time elapsed from beginning the block to catheter placement
measure: Incremental Cost of Femoral Nerve Blocks
timeFrame: postoperative period when block is used
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ehab Farag, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, M.D.
role: STUDY_CHAIR
References: