Clinical trial NCT04084288: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Pain, Postoperative
Acupuncture
Keywords: Acupuncture, Total Knee Replacement
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Low-dose Opioid Regimen Adherence
timeFrame: postoperative day 0 to postoperative day 30
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
measure: Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
timeFrame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
measure: Duration of Neuraxial Anesthesia in Hours
timeFrame: postoperative day 1
measure: Deviation From Prescribed Oral Pain Regimen
timeFrame: Postoperative day 30
measure: Number of Participants With Side Effects on POD1 and During the PACU Stay
timeFrame: PACU, Postoperative day 1
measure: Postoperative Range of Motion
timeFrame: 6 weeks postoperative (surgeon office visit)
measure: Tourniquet Time
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Stephanie Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: