N/A
N=453
Comparison of 3 Techniques for Ultrasound-guided Femoral Nerve Catheter Insertion
Total Knee Replacement Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00927368 ↗Enrolled (actual)
453
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Time Weighted Average Verbal Response Scale Pain Score — 3.52; 3.24; 3.40 units on a scale — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ultrasound guidance alone (Procedure); ultrasound guidance and needle stimulation (Procedure); ultrasound guidance and catheter stimulation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Weighted Average Verbal Response Scale Pain Score |
3.52; 3.24; 3.40 | < 0.001 sig |
| PRIMARY Opioid Consumption |
57; 58; 55 | 0.04 sig |
| SECONDARY Block Performance Time |
110; 150; 177 | 0.11 |
| SECONDARY Incremental Cost of Femoral Nerve Blocks |
14; 36; 50 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00927368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.