Acupuncture for Low-Dose Opioid for TKA Replacement

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Acupuncture; Pain, Postoperative; Knee Osteoarthritis

Treatments: Device: Peripheral Nerve Stimulator; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04084288

2019-1193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Postoperative Acupuncture

Experimental group

Description:

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)

Treatment:

Other: Acupuncture

Device: Peripheral Nerve Stimulator