Acupuncture for Low-Dose Opioid for TKA Replacement

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084288
• Other study ID #: 2019-1193
• Status: Completed
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: October 2, 2020

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2, 2020
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Knee Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

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).

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Duration of Neuraxial Anesthesia in Hours		postoperative day 1
Secondary	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
Secondary	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
Secondary	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)
Secondary	Tourniquet Time	Duration of time the tourniquet is inflated intraoperatively. Measured in minutes	Intraoperatively