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

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Hip Surgery; Acupuncture; Opioid Use

Treatments: Other: No Acupuncture Group; Device: Auricular Trauma Protocol (ATP) Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05384860

2021-1496

Details and patient eligibility

About

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.

Enrollment: 484 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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484 participants in 2 patient groups, including a placebo group

Active Acupuncture Group

Active Comparator group

Description:

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.

Treatment:

Device: Auricular Trauma Protocol (ATP) Acupuncture

Placebo No Acupuncture Group

Placebo Comparator group

Description:

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

Treatment:

Other: No Acupuncture Group