Acupuncture for Low-Dose Opioid for TKA Replacement

Study Overview
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Brief Summary
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The majority of patients undergoing total knee replacement(TKR) 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.

Detailed Description
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This is a prospective cohort study to assess the feasibility of patients to undergo TKR while adhering to a low-dose opioid regimen by using a multimodal analgesic approach that includes intraoperativeauricular acupuncture. We hypothesize that it will be feasible to maintain a low-dose opioid regimen during TKR while followingthe intraoperative auricular acupuncture protocol, and that patients will be satisfied with their pain control with a low incidence of adverse events.

Official Title
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Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study

Conditions
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Knee Osteoarthritis, Pain, Postoperative, Acupuncture

Intervention / Treatment
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* Other: Acupuncture
* Device: Peripheral Nerve Stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postoperative Acupuncture<br>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) | Other: Acupuncture<br>* 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<br>Device: Peripheral Nerve Stimulator<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-dose Opioid Regimen Adherence | The number 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. | postoperative day 0 to postoperative day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption | Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints | post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 | 
| Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | 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. | post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 | 
| Duration of Neuraxial Anesthesia in Hours |  | postoperative day 1 | 
| Deviation From Prescribed Oral Pain Regimen | Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30 | Postoperative day 30 | 
| Number of Participants With Side Effects on POD1 and During the PACU Stay | Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1 | PACU, Postoperative day 1 | 
| Postoperative Range of Motion | 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 a score that is achieved by adding extension and flexion together. It is measured in degrees. (example: flexion: 118 + extension:1 = score: 119) | 6 weeks postoperative (surgeon office visit) | 
| Tourniquet Time | Duration of time the tourniquet is inflated intraoperatively. Measured in minutes | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Total Knee Replacement