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Acupuncture for Low-Dose Opioid TKA

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ClinicalTrials.gov Identifier: NCT04084288
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
The majority of patients undergoing total knee replacement rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. The aim of this cohort study is to determine the incidence rate of patients who are able to maintain a low dose opioid regimen after TKR with the use of a multimodal approach that includes intraoperative auricular acupuncture protocol.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Pain, Postoperative Acupuncture Device: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Postoperative Acupuncture

Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request.

A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room.

A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon)

Device: Acupuncture
Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed




Primary Outcome Measures :
  1. Low-dose opioid regimen adherence [ Time Frame: postoperative day 0 to postoperative day 30 ]
    The incidence of patients who maintain a low-dose opioid regimen (15 pills or less of 5mg oxycodone or 112.5 OME [oral morphine equivalents]) from postoperative day (POD) 0 to POD 30 throughout their Total Knee Replacement


Secondary Outcome Measures :
  1. Total opioid consumption [ Time Frame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 ]
    Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints

  2. Numerical Rating Scale (NRS) pain scores at rest and with movement [ Time Frame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 ]
    Numerical Rating Scale (NRS) pain scores at rest and with movement. NRS pain is measured from 0 to 10, with 0 being the no pain whatsoever and 10 being the worst pain imaginable.

  3. Satisfactory with Postoperative Analgesia [ Time Frame: postoperative day 1 ]
    Patients report their satisfaction with their postoperative analgesia on postoperative day 1 from 0 (extremely unsatisfied) to 10 (extremely satisfied)

  4. Satisfaction with overall protocol [ Time Frame: Postoperative day 30 ]
    Patients report their satisfaction with their overall postoperative analgesic protocol on postoperative day 30 from 0 (extremely unsatisfied) to 10 (extremely satisfied)

  5. Deviation from prescribed oral pain regimen [ Time Frame: Postoperative day 30 ]
    Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30

  6. Incidence of nausea, vomiting, pruritus, constipation [ Time Frame: PACU, Postoperative day 1 ]
    Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1

  7. Postoperative Range of Motion [ Time Frame: 6 weeks postoperative (surgeon office visit) ]
    Postoperative range of motion measured at the 6 week surgeon office visit. This is being measured by either the physician or their PA and is extension and flexion. It is measured in degrees

  8. Tourniquet Time [ Time Frame: Intraoperatively ]
    Duration of time the tourniquet is inflated intraoperatively. Measured in minnutes



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA of 1 or 2
  • Age 18-70
  • Undergoing primary total knee replacement
  • Desire to attempt a low opioid or opioid free pathway

Exclusion Criteria:

  • NonEnglish speaking
  • Patients with the inability to understand or follow study protocol
  • Opioid use in the last 6 weeks or chronic pain patient
  • Cannot receive neuraxial anesthesia and/or peripheral nerve block
  • Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease)
  • Patients with implanted cardiac device such as a pacemaker or AICD
  • Active ear infection
  • Nonnative ear, previous scarring or surgical manipulation of ear
  • Patients with gauges or other deforming ear piercing (small nondeforming ear piercings are ok) present in ears
  • Allergy to nickel

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): NCT04084288


Contacts
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Contact: George Birch, BS 212-774-7377 birchg@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: George Birch, BS    212-773-7377    birchg@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04084288     History of Changes
Other Study ID Numbers: 2019-1193
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hospital for Special Surgery, New York:
Acupuncture, Total Knee Replacement
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Pain, Postoperative
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms