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Completed

NCT Number: NCT05384860

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.

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Key information

Conditions

Acupuncture Hip Surgery Opioid Use

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular Trauma Protocol (ATP) Acupuncture

Device

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 Group

Other

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

Primary outcomes

  1. Opioid Usage

    Time frame: 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 outcomes

  1. NRS Pain Scores

    Time frame: 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

  2. Satisfaction with Protocol

    Time frame: 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.

  3. Post-operative Nausea & Vomiting (PONV)

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

    Incidence of nausea, vomiting, pruritus, constipation

  4. Range of Motion

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

    Postoperative range of motion (extension and flexion)

  5. Pain Catastrophizing Scale (PCS)

    Time frame: 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.

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

    Time frame: 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.

  7. Hours to Discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 20, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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