Ultrasound Guided Femoral Nerve Block and Ultrasound Guided Femoral Nerve Block With Peripheral Nerve Stimulation in Knee Replacement Surgery
This study is currently recruiting participants.
Verified August 2011 by Outcomes Research Consortium
Sponsor:
Outcomes Research Consortium
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00927368
First received: June 24, 2009
Last updated: August 31, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Total Knee Replacement Surgery |
Procedure: stimulation needle and stimulating catheter Procedure: nerve catheter with stimulating needle Procedure: guided femoral nerve block without stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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. |
Resource links provided by NLM:
Further study details as provided by Outcomes Research Consortium:
Primary Outcome Measures:
- catheter insertion technique comparison [ Time Frame: 4 years ] [ Designated as safety issue: No ]determine optimal technique for ultrasound guided placement of nerve catheters
Secondary Outcome Measures:
- pain assessment [ Time Frame: 4 years ] [ Designated as safety issue: No ]pain assessment post operative as compared to nerve block technique
| Estimated Enrollment: | 420 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: stimulation needle and stimulating catheter
ultrasound guided femoral nerve catheter using a stimulation needle and a stimulating catheter
|
Procedure: stimulation needle and stimulating catheter
ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter
|
|
Active Comparator: nerve catheter with stimulating needle
ultrasound guided femoral nerve catheter using a stimulation needle but non stimulating catheter
|
Procedure: nerve catheter with stimulating needle
Ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter
|
|
Active Comparator: femoral nerve block without stimulation
ultrasound guided femoral nerve block without stimulation
|
Procedure: guided femoral nerve block without stimulation
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927368
Contacts
| Contact: Ehab Farag, M.D. | 216-445-7550 | farage@ccf.org |
| Contact: Gretchen A Upton | 216-444-3289 | uptong@ccf.org |
Locations
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
| Principal Investigator: | Ehab Farag, M.D. | The Cleveland Clinic |
| Study Chair: | Daniel I Sessler, M.D. | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Ehab Farag M.D., Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00927368 History of Changes |
| Other Study ID Numbers: | 09-340 |
| Study First Received: | June 24, 2009 |
| Last Updated: | August 31, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Outcomes Research Consortium:
|
TKA total knee replacement stimulating nerve catheters |
ClinicalTrials.gov processed this record on May 22, 2013