Skip to main content
OpenTrials
Completed

NCT Number: NCT04084288

Acupuncture for Low-Dose Opioid for TKA Replacement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

Primary outcomes

  1. Low-dose Opioid Regimen Adherence

    Time frame: 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 outcomes

  1. Total Opioid Consumption

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

    Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints

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

    Time frame: 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.

  3. Duration of Neuraxial Anesthesia in Hours

    Time frame: postoperative day 1

    Duration of neuraxial anesthesia is defined as number of hours between anesthesia start time to anesthesia stop time.

  4. Deviation From Prescribed Oral Pain Regimen

    Time frame: 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

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

    Time frame: 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

  6. Postoperative Range of Motion

    Time frame: 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)

  7. Tourniquet Time

    Time frame: Intraoperatively

    Duration of time the tourniquet is inflated intraoperatively. Measured in minutes

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.