MedTrace Logo

Opioid Induced Loss of Local Anesthetic Potency in Patients Undergoing Total Knee Arthroplasty

NCT03294174 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2018-11-09

No results posted yet for this 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 growing population of opioid tolerant patients

Conditions

  • Opioid Tolerance, Opioid Naive, Opioid Exposure

Interventions

DRUG

Ropivacaine injection

Ropivacaine administered to provide nerve block

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294174 on ClinicalTrials.gov