Acupuncture for Low-Dose Opioid for TKA Replacement

Not Applicable

Completed

Conditions: Knee Osteoarthritis
Pain, Postoperative
Acupuncture

Interventions: Other: Acupuncture
Device: Peripheral Nerve Stimulator

Registration Number: NCT04084288

Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Postoperative Acupuncture	Peripheral Nerve Stimulator	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)
Postoperative Acupuncture	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)

Primary Outcome Measures

Name	Time	Method
Low-dose Opioid Regimen Adherence	postoperative day 0 to postoperative day 30	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.

Secondary Outcome Measures

Name	Time	Method
Total Opioid Consumption	post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30	Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement	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.
Duration of Neuraxial Anesthesia in Hours	postoperative day 1	Duration of neuraxial anesthesia is defined as number of hours between anesthesia start time to anesthesia stop time.
Deviation From Prescribed Oral Pain Regimen	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
Number of Participants With Side Effects on POD1 and During the PACU Stay	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
Postoperative Range of Motion	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 a score that is achieved by adding extension and flexion together. It is measured in degrees. (example: flexion: 118 + extension:1 = score: 119)
Tourniquet Time	Intraoperatively	Duration of time the tourniquet is inflated intraoperatively. Measured in minutes