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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• ASA status of 1 or 2

• Ages 18-80

• Undergoing a total hip replacement

• Ability to follow study protocol

• English-speaking

Locations
United States
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
Marko Popovic, BS
popovicm@hss.edu
646-797-8948
Backup
Pa Thor, PhD
thorp@hss.edu
646-797-8535
Time Frame
Start Date: 2022-07-06
Estimated Completion Date: 2026-01
Participants
Target number of participants: 484
Treatments
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.
Placebo_comparator: Placebo No Acupuncture Group
These patients will not receive acupuncture treatment during surgery, their surgery will continue as normal.
Related Therapeutic Areas
Sponsors
Leads: Hospital for Special Surgery, New York

This content was sourced from clinicaltrials.gov