Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery
- Conditions
- Opioid UseAcupunctureHip Surgery
- Interventions
- Device: Auricular Trauma Protocol (ATP) AcupunctureOther: No Acupuncture Group
- Registration Number
- NCT05384860
- Lead Sponsor
- Hospital for Special Surgery, New York
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 484
- ASA status of 1 or 2
- Ages 18-80
- Undergoing a total hip replacement
- Ability to follow study protocol
- English-speaking
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Acupuncture Group Auricular Trauma Protocol (ATP) Acupuncture For the patients randomized to the acupuncture group, once sedation has been deemed adequate by the anesthesiologist, 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. Placebo No Acupuncture Group No Acupuncture Group These patients will not receive acupuncture treatment during surgery, their surgery will continue as normal.
- Primary Outcome Measures
Name Time Method Opioid Usage Day 30 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.
- Secondary Outcome Measures
Name Time Method NRS Pain Scores Post-operatively in: PACU (post-anesthesia care unit) immediately post-operation, Day 1, Day 2, Day 14 & Day 30 NRS pain scores at rest and with movement
Pain Catastrophizing Scale (PCS) Pre-operative 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.
Center for Epidemiologic Studies Short Depression Scale & Anxiety Scale (CES-D) Pre-operative 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.
Satisfaction with Protocol Day 30 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.
Post-operative Nausea & Vomiting (PONV) Post-operatively in: PACU (post-anesthesia care unit), Day 1 Incidence of nausea, vomiting, pruritus, constipation
Range of Motion Post-operatively on: Day 1 and Day 14 Postoperative range of motion (extension and flexion)
Hours to Discharge Will be assessed up to 4 days post-operatively or until patient leaves hospital. 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.
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States