Acupuncture for Low-Dose Opioid for TKA Replacement

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Knee Osteoarthritis; Acupuncture
• Intervention / Treatment: Other: Acupuncture; Device: Peripheral Nerve Stimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

Other: 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; Device: Peripheral Nerve Stimulator; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Stephanie Cheng, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Actual): October 2, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture, Total Knee Replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Knee
• Other Study ID Numbers: 2019-1193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. This will be done to achieve aims in the approved proposal. Proposals should be directed to chengs@hss.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No