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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294174
Recruitment Status : Terminated (Responsible Investigator left institution)
First Posted : September 26, 2017
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh

Brief 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


Condition or disease Intervention/treatment
Opioid Tolerance, Opioid Naive, Opioid Exposure Drug: Ropivacaine injection

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Opioid Induced Loss of Local Anesthetic Potency in Patients Undergoing Total Knee
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Opioid naive
Patients who have not been exposed to opioids, but will receive ropivacaine injection
Drug: Ropivacaine injection
Ropivacaine administered to provide nerve block
Other Name: ropivacaine nerve block

Opioid exposure
Patients who have been exposed to(> 6months), but not currently taking opioids, but will receive ropicacaine injection
Drug: Ropivacaine injection
Ropivacaine administered to provide nerve block
Other Name: ropivacaine nerve block

opioid tolerance
Patients who have been actively taking opioids with a tolerant dose based on FDA guideline, but will receive ropivacaine injection
Drug: Ropivacaine injection
Ropivacaine administered to provide nerve block
Other Name: ropivacaine nerve block




Primary Outcome Measures :
  1. Sensory and motor function loss after nerve block procedures [ Time Frame: within first 30 min ]
    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)


Secondary Outcome Measures :
  1. pain [ Time Frame: within 1 hour ]
    VAS pain score will be used to assess pain level

  2. sodium channel subunit changes in synovial tissues [ Time Frame: Synovial tissues will be extracted within 1 hour after nerve block. Western blotting techniques will be used to quantify the changes in sodium channel subunit level ]
    changes in sodium channel subunit level


Biospecimen Retention:   Samples With DNA
Synovial tissues will be collected from each study patient


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants of the study will belong to one of the three groups: opioid naive, opioid history (those with a history of opioid use, but who are not currently on opioids) and opioid tolerant (those using opioids at the time of surgery)
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists Classification 1,2 and 3;
  • Age between 18-80;
  • Both males and females of all races
  • Receive total knee arthroplasty (TKA)
  • Agree to receive peripheral nerve blocks for postoperative pain control

Participants of the study will belong to one of the three groups: opioid naive, opioid history (those with a history of opioid use, but who are not currently on opioids) and opioid tolerant (those using opioids at the time of surgery)

Exclusion Criteria:

  • Intolerance and/or known allergy to opioids and/or LAs;
  • TKA due to trauma;
  • Use of general anesthesia for the operation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294174


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
University of Pittsburgh
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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03294174    
Other Study ID Numbers: PRO15020146
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw data available upon request
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents