NCT04084288

Acupuncture for Low-Dose Opioid for TKA Replacement

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Pain, Postoperative
• Acupuncture

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-08-21
• Primary completion: 2020-10-02
• Completion: 2020-10-02
• First posted: 2019-09-10
• Last updated: 2024-12-27
• Results posted: 2022-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study