Back to resultsAcupuncture for Low-Dose Opioid for TKA Replacement
Primary Purpose
Knee Osteoarthritis, Pain, Postoperative, Acupuncture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Peripheral Nerve Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Acupuncture, Total Knee Replacement
Eligibility Criteria
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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Postoperative Acupuncture
Arm 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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total Opioid Consumption
Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints
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.
Duration of Neuraxial Anesthesia in Hours
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
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
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)
Tourniquet Time
Duration of time the tourniquet is inflated intraoperatively. Measured in minutes
Full Information
NCT ID
NCT04084288
First Posted
September 9, 2019
Last Updated
April 7, 2022
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT04084288
Brief Title
Acupuncture for Low-Dose Opioid for TKA Replacement
Official Title
Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Pain, Postoperative, Acupuncture
Keywords
Acupuncture, Total Knee Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postoperative Acupuncture
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Peripheral Nerve Stimulator
Intervention Description
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 Outcome Measure Information:
Title
Low-dose Opioid Regimen Adherence
Description
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.
Time Frame
postoperative day 0 to postoperative day 30
Secondary Outcome Measure Information:
Title
Total Opioid Consumption
Description
Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints
Time Frame
post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Title
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
Description
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.
Time Frame
post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Title
Duration of Neuraxial Anesthesia in Hours
Time Frame
postoperative day 1
Title
Deviation From Prescribed Oral Pain Regimen
Description
Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30
Time Frame
Postoperative day 30
Title
Number of Participants With Side Effects on POD1 and During the PACU Stay
Description
Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1
Time Frame
PACU, Postoperative day 1
Title
Postoperative Range of Motion
Description
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)
Time Frame
6 weeks postoperative (surgeon office visit)
Title
Tourniquet Time
Description
Duration of time the tourniquet is inflated intraoperatively. Measured in minutes
Time Frame
Intraoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Cheng, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Acupuncture for Low-Dose Opioid for TKA Replacement
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