Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery
NCT ID: NCT05384860
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
484 participants
INTERVENTIONAL
2022-07-06
2025-04-04
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Treatment assignments were transcribed onto notecards and sealed in opaque, consecutively numbered envelopes by a research assistant not otherwise involved in the trial.
After patient consent and prior to anesthesia start, the research assistant involved in the trial handed the randomization envelope to the medical acupuncturist. All patients and research assistants involved with data collection will be blinded to the group allocation.
Randomization lists will be accessed by an intra-op monitor RA who is not otherwise involved in the study in any other aspect.
TREATMENT
DOUBLE
Study Groups
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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.
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 No Acupuncture Group
These patients will not receive acupuncture treatment during surgery, their surgery will continue as normal.
No Acupuncture Group
This involves not receiving the acupuncture treatment and surgery going entirely as normal according to the hospital's standard of care.
Interventions
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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.
No Acupuncture Group
This involves not receiving the acupuncture treatment and surgery going entirely as normal according to the hospital's standard of care.
Eligibility Criteria
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Inclusion Criteria
* Ages 18-80
* Undergoing a total hip replacement
* Ability to follow study protocol
* English-speaking
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Stephanie Cheng, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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Other Identifiers
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2021-1496
Identifier Type: -
Identifier Source: org_study_id
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