Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery

Hospital for Special Surgery, New York484 enrolled

Overview

At this time, no formal ERAS (enhanced recovery after surgery) protocol exists for THR that incorporates perioperative acupuncture. Developing, and more importantly, validating a preliminary fast-track protocol for THR can have a significant impact on reducing recovery time and improving the rate at which this subgroup of surgeries is done on an outpatient basis. Furthermore, previous studies of acupuncture as an adjunctive therapy for postoperative analgesia have primarily investigated patient satisfaction rather than the impact on postoperative opioid consumption. The majority of studies also place acupuncture needles preoperatively, rather than following induction of anesthesia (intra-operatively). This study hopes to show that placing auricular therapy needles intraoperatively is a feasible part of a protocol for motivated patients to minimize opioids after total knee arthroplasty. The prospect of incorporating intraoperative acupuncture as an adjunct into said protocol is very attractive given its low cost, its safety profile, its ease of administration, and the growing evidence supporting its efficacy. This study would provide further clarity on whether perioperative acupuncture can effectively reduce hospital length of stay and post-operative opioid consumption, in addition to evaluating the role of perioperative acupuncture in improving recovery after THR as part of a multimodal fast-track protocol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

484

Conditions

Acupuncture

Interventions

Auricular Trauma Protocol (ATP) AcupunctureDEVICE

Small filiform (needle) like needles use low frequency electrostimulation at eight ear points for 60 minutes while patient is sedated during surgery. All other aspects of the surgical procedure will go as planned according to the hospital's standard of care.

No Acupuncture GroupOTHER

This involves not receiving the acupuncture treatment and surgery going entirely as normal according to the hospital's standard of care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ASA status of 1 or 2 * Ages 18-80 * Undergoing a total hip replacement * Ability to follow study protocol * English-speaking Exclusion Criteria: * Non-English speaking * Chronic opioids use (6 weeks or more) * Contraindication to neuraxial anesthesia or peripheral nerve block * Intending to receive general anesthesia * Contraindication to intra-op protocol * Implanted cardiac device (i.e. pacemaker) * Active ear infection * Non-native ear, previous scarring or surgery * Ear gauges or other deforming ear piercing * Allergy to Nickel

Outcomes

Primary Outcomes

Opioid Usage

The primary outcome is the incidence of patients who maintain a low-dose opioid regimen (71.5 OME or less) out to 30 days post-op. Patient intake of opioid medication will be measured up to the 30 days post-operation.

Time frame: Day 30

Secondary Outcomes

NRS Pain Scores

NRS pain scores at rest and with movement

Time frame: Post-operatively in: PACU (post-anesthesia care unit) immediately post-operation, Day 1, Day 2, Day 14 & Day 30

Satisfaction with Protocol

Satisfaction with the whole protocol/study experience and pain management throughout surgery and recovery. Patients will be asked to rate their satisfaction with the study, care provided and pain management on a scale of 1-10 with 1 being least satisfied and 10 being most satisfied.

Time frame: Day 30

Post-operative Nausea & Vomiting (PONV)

Incidence of nausea, vomiting, pruritus, constipation

Time frame: Post-operatively in: PACU (post-anesthesia care unit), Day 1

Range of Motion

Postoperative range of motion (extension and flexion)

Time frame: Post-operatively on: Day 1 and Day 14

Pain Catastrophizing Scale (PCS)

13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. It is a self-reported measure with items scored from 0-4 with 4 being the most catastrophic. The higher a patient's total scores the more catastrophic their thoughts are in relation to pain.

Time frame: Pre-operative

Center for Epidemiologic Studies Short Depression Scale & Anxiety Scale (CES-D)

20 questions that asks about various symptoms of depression as they have occurred in the past week. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Total scores range from 0 to 60, with higher scores indicated greater depressive symptoms.

Time frame: Pre-operative

Hours to Discharge

The total number of hours patients spend in the hospital until discharge from the hospital. This will be measured from the start of surgery in the OR until discharge from hospital.

Time frame: Will be assessed up to 4 days post-operatively or until patient leaves hospital.