Phase 4
Completed N=45
Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks
Source: ClinicalTrials.gov NCT00923598 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Quadriceps Femoris Muscle Strength Maximum Voluntary Isometric Contraction (MVIC) — 13; 12 newtons — p=0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quadriceps Femoris Muscle Strength Maximum Voluntary Isometric Contraction (MVIC) |
13; 12 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Primary, bilateral TKA
- Age 18 years or older
- Postoperative analgesic pain includes bilateral continuous femoral nerve blocks
Exclusion Criteria
- Chronic, high-dose opioid use
- History of opioid abuse
- Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
- Pregnancy
- Incarceration
Data sourced from ClinicalTrials.gov (NCT00923598). 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. Informational only — not medical advice.