Acupuncture for Low-Dose Opioid for TKA Replacement

NCT04084288 | Completed Results FDA Device

• 1 other identifier: 2019-1193
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Pain, Postoperative; Acupuncture

Keywords

Acupuncture, Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Total Opioid Consumption

  post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30

• Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement

  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

  Postoperative day 30

• Number of Participants With Side Effects on POD1 and During the PACU Stay

  PACU, Postoperative day 1

Study Arms (1)

Postoperative Acupuncture

EXPERIMENTAL

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; Device: Peripheral Nerve Stimulator

Interventions

Acupuncture OTHER

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

Postoperative Acupuncture

Peripheral Nerve Stimulator DEVICE

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).

Postoperative Acupuncture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Dr. Stephanie Cheng
• Organization: Hospital for Special Surgery

chengs@hss.edu

212-606-1206

Study Officials

• Stephanie Cheng, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 10, 2019
• Study Start: August 21, 2019
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: December 27, 2024
• Results First Posted: May 5, 2022

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

US (1)