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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384860
• Other study ID #: 2021-1496
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: Marko Popovic, BS
• Phone: 646-797-8948
• Email: popovicm[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Hip Surgery
• Opioid Use

Intervention

Device:
• 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.

Other:
• No Acupuncture Group
This involves not receiving the acupuncture treatment and surgery going entirely as normal according to the hospital's standard of care.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NRS Pain Scores	NRS pain scores at rest and with movement	Post-operatively in: PACU (post-anesthesia care unit) immediately post-operation, Day 1, Day 2, Day 14 & Day 30
Secondary	Satisfaction with Protocol	Satisfaction with the whole protocol/study experience and pain management throughout surgery and recovery. Patients will be asked to rate their satisfaction with the study, care provided and pain management on a scale of 1-10 with 1 being least satisfied and 10 being most satisfied.	Day 30
Secondary	Post-operative Nausea & Vomiting (PONV)	Incidence of nausea, vomiting, pruritus, constipation	Post-operatively in: PACU (post-anesthesia care unit), Day 1
Secondary	Range of Motion	Postoperative range of motion (extension and flexion)	Post-operatively on: Day 1 and Day 14
Secondary	Pain Catastrophizing Scale (PCS)	13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. It is a self-reported measure with items scored from 0-4 with 4 being the most catastrophic. The higher a patient's total scores the more catastrophic their thoughts are in relation to pain.	Pre-operative
Secondary	Center for Epidemiologic Studies Short Depression Scale & Anxiety Scale (CES-D)	20 questions that asks about various symptoms of depression as they have occurred in the past week. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Total scores range from 0 to 60, with higher scores indicated greater depressive symptoms.	Pre-operative
Secondary	Hours to Discharge	The total number of hours patients spend in the hospital until discharge from the hospital. This will be measured from the start of surgery in the OR until discharge from hospital.	Will be assessed up to 4 days post-operatively or until patient leaves hospital.