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Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for 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: NCT02276495
Recruitment Status : Unknown
Verified January 2019 by Coral Sun, University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : October 28, 2014
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Coral Sun, University of California, Irvine

Brief Summary:
The purpose of the study is to determine the effect of a single injection adductor canal block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).

Condition or disease Intervention/treatment Phase
Pain Management Other: ACB Control - 20 ml saline injection for ACB Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty?
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACB Control + Local Infiltration
ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline
Other: ACB Control - 20 ml saline injection for ACB
Adductor Canal Block Control (20 ml saline injection)

Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

100 mLs of a solution containing:

Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)


Experimental: ACB Study + Local infiltration
ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline
Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Adductor Canal Block Study (20 ml 0.5% Ropivacaine)

Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

100 mLs of a solution containing:

Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)


Experimental: ACB Study Only
ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Adductor Canal Block Study (20 ml 0.5% Ropivacaine)




Primary Outcome Measures :
  1. Pain Score [ Time Frame: within 24 hours postoperative ]
    The primary outcome variable of interest is the average maximum pain score within 24 hours postoperative.


Secondary Outcome Measures :
  1. Opioid Use [ Time Frame: within 24 hours postoperative ]
    24 Hour post-surgical opioid use

  2. PACU Opioid Use [ Time Frame: Postoperative (while in PACU), an expected average of 60 minutes ]
    PACU opioid use

  3. Daily Opioid Use [ Time Frame: duration of hospital stay, an expected average of 3 days ]
    Average daily opioid use during hospitalization

  4. Average NRS Pain Score [ Time Frame: within 24 hours postoperative ]
    Average NRS pain score

  5. Length of Stay [ Time Frame: duration of hospital stay, an expected average of 3 days ]
    Length of hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females age 18+ years old having total knee arthroplasty (TKA) at UCI Medical Center
  • American Society of Anesthesiologists physical status I to III

Exclusion Criteria:

  • Allergy to local anesthetics
  • Pregnancy
  • Nursing Mothers
  • Children <18 years of age
  • Renal impairment (GFR<60 mL/min/1.73m2)
  • Hepatic Impairment (active hepatitis, elevated AST or ALT, jaundice)
  • Opioid tolerant patients (defined as greater than 30 mg Morphine equivalent consumed daily)
  • Patients that are diabetic with peripheral neuropathy
  • BMI greater than 40

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): NCT02276495


Contacts
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Contact: Coral Sun, MD (714) 456-5501
Contact: Cecilia Canales, MPH (714) 456-8998 canalesc@uci.edu

Locations
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United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Principal Investigator: Coral Sun, MD         
Sub-Investigator: Ran Schwarzkopf, MD         
Sub-Investigator: Kyle Ahn, MD         
Sub-Investigator: Padma Gulur, MD         
Sub-Investigator: Jane Ahn, MD         
Sub-Investigator: Joseph Rinehart, MD         
Sub-Investigator: Diana Diaz, MD         
Sub-Investigator: Matthew Brown, MD         
Sub-Investigator: Hao Ho, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Coral Sun, MD University of California, Irvine
Publications:
Robbins SM, Rastogi R, McLaughlin T-L. Predicting Acute Recovery of Physical Function Following Total Knee Joint Arthroplasty. J. Arthroplasty. 2013. Available at: http://www.sciencedirect.com/science/article/pii/S088354031300466X. Accessed December 17, 2013.

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Responsible Party: Coral Sun, Assistant Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02276495    
Other Study ID Numbers: UCIANES06
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Keywords provided by Coral Sun, University of California, Irvine:
pain management for total knee arthroplasty
Additional relevant MeSH terms:
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Ketorolac
Clonidine
Epinephrine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors