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NCT03294174 · ClinicalTrials.gov registry record
Opioid Induced Loss of Local Anesthetic Potency in Patients Undergoing Total Knee Arthroplasty
A clinical trial, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- 48
- Enrollment target
NCT03294174: Clinical Trial study, sponsored by University of Pittsburgh.
NCT03294174 is a clinical trial that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294174 was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- 48 participants
- Enrollment target
Study Summary
Peripheral nerve blocks with local anesthetics (LAs) have become an integral part of postoperative pain management particularly for patients undergoing major limb procedures such as such as Total Knee Arthroplasty (TKA). And while postoperative pain management in patients with a history of chronic opioid use may be difficult with systemic opioids because of opioid tolerance, there is anecdotal evidence suggesting that these patients may also be less responsive to LAs. Preliminary data from pre-clinical animal study show that there is a decreased LA potency in blocking sciatic nerve in opioid tolerant rats. And the decrease in LA potency is reversed by the knock-down of the beta4 subunits of Voltage-gated sodium channels along the sciatic nerves, suggesting the opioid induced intrinsic changes in the peripheral nerve as an underlying mechanism for opioid induced loss of LA potency. Study Goals: To determine the extent to which the changes in beta4 subunits of voltage-gated sodium channels are reflected in surgical patients. Experimental Design / methodology: This is a prospective, double-blind, active treatment controlled study. TKA Patients who receive nerve blocks will be grouped according to their history of pre-operative opioid use, and then tested for local anesthetic use for nerve block. Synovial tissues will also be collected for the analysis of beta4 subunits. Subject population: Patients who are scheduled for TKA procedure, and agree to receive peripheral nerve block for postoperative pain control, will be recruited for the study. Patients will participate in one of the three study groups: opioid naive, opioid history and opioid tolerant. 30 patients for each group with a total of 90 patients will be recruited. This study will not only determine the extent to which the preclinical findings are reflected in clinical patients, but also identify the underlying mechanisms that may suggest strategies for more effective post-operative pain management in the gr
Primary Outcome
Sensory block is assessed by evaluating the presence and absence of response to thermal stimulation applied to the central sensory region of the blocked nerve, using Medoc 5x5 thermode (see details in description)
Interventions
- DRUG Ropivacaine injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Est. Completion | 2017-06 |
Why NCT03294174 stopped before completion
NCT03294174 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 48 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ropivacaine injection is the first listed.
NCT03294174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03294174 about?
NCT03294174 is a clinical study titled "Opioid Induced Loss of Local Anesthetic Potency in Patients Undergoing Total Knee Arthroplasty". Peripheral nerve blocks with local anesthetics (LAs) have become an integral part of postoperative pain management particularly for patients undergoing major limb procedures such as such as Total Knee Arthroplasty (TKA). And while postoperative pain management in patients with a history of chronic o...
What is the current status of trial NCT03294174?
This trial is currently terminated. The enrollment target is 48 participants. Estimated completion is 2017-06.
What interventions are being tested in trial NCT03294174?
The interventions under investigation include: Ropivacaine injection (DRUG).
Who is sponsoring clinical trial NCT03294174?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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