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

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 Overview

• Status: Completed
• Conditions: Hip Surgery; Opioid Use; Acupuncture
• Intervention / Treatment: Device: Auricular Trauma Protocol (ATP) Acupuncture; Other: No Acupuncture Group

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Acupuncture Group; 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.	Device: Auricular Trauma Protocol (ATP) Acupuncture; 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.
Placebo Comparator: Placebo No Acupuncture Group; These patients will not receive acupuncture treatment during surgery, their surgery will continue as normal.	Other: No Acupuncture Group; This involves not receiving the acupuncture treatment and surgery going entirely as normal according to the hospital's standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain Scores	NRS pain scores at rest and with movement	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.	Day 30
Post-operative Nausea & Vomiting (PONV)	Incidence of nausea, vomiting, pruritus, constipation	Post-operatively in: PACU (post-anesthesia care unit), Day 1
Range of Motion	Postoperative range of motion (extension and flexion)	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.	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.	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.	Will be assessed up to 4 days post-operatively or until patient leaves hospital.

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Stephanie Cheng, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: acupuncture; hip surgery
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: 2021-1496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes