Clinical trial NCT05384860: Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery
Official title: Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acupuncture
Hip Surgery
Opioid Use
Keywords: hip surgery
acupuncture
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Opioid Usage
timeFrame: Day 30
Secondary outcomes:
measure: NRS Pain Scores
timeFrame: Post-operatively in: PACU (post-anesthesia care unit) immediately post-operation, Day 1, Day 2, Day 14 & Day 30
measure: Satisfaction with Protocol
timeFrame: Day 30
measure: Post-operative Nausea & Vomiting (PONV)
timeFrame: Post-operatively in: PACU (post-anesthesia care unit), Day 1
measure: Range of Motion
timeFrame: Post-operatively on: Day 1 and Day 14
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Pre-operative
measure: Center for Epidemiologic Studies Short Depression Scale & Anxiety Scale (CES-D)
timeFrame: Pre-operative
measure: Hours to Discharge
timeFrame: Will be assessed up to 4 days post-operatively or until patient leaves hospital.
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Stephanie Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: