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

NCT05384860 | Completed FDA Device

• 1 other identifier: 2021-1496
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Surgery; Opioid Use; Acupuncture

Keywords

hip surgery; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• NRS Pain Scores

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

• Satisfaction with Protocol

  Day 30

• Post-operative Nausea & Vomiting (PONV)

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

• Range of Motion

  Post-operatively on: Day 1 and Day 14

• Pain Catastrophizing Scale (PCS)

  Pre-operative

Study Arms (2)

Active Acupuncture Group

ACTIVE COMPARATOR

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

Placebo No Acupuncture Group

PLACEBO COMPARATOR

These patients will not receive acupuncture treatment during surgery, their surgery will continue as normal.

Other: No Acupuncture Group

Interventions

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.

Active Acupuncture Group

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.

Placebo No Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA status of 1 or 2
• Ages 18-80
• Undergoing a total hip replacement
• Ability to follow study protocol
• English-speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Stephanie Cheng, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both patients and research assistants (RAs)collecting data from the patients will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects were randomly assigned to receive Acupuncture, or No Acupuncture based on a 1:1 schedule with blocks of four created prior to study initiation using SAS version 9.4 (SAS Institute; Cary, NC) by a member of the biostatistics core not otherwise involved in the trial. 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.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 20, 2022
• Study Start: July 6, 2022
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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.

Locations

US (1)