Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain

Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture; Anesthesia; Anterior Cruciate Ligament Injury; ACL; ACL Injury
• Intervention / Treatment: Other: Acupuncture + Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing ACL Surgery with a participating surgeon
• English Speaking
• Patients at least 12 years old
• Planned spinal anesthesia without peripheral nerve block (rescue block is okay)

Exclusion Criteria:

• Patients under the age of 12
• Non-English speaking patients
• Patients planning on having general anesthesia
• Planned preop peripheral nerve block
• Patients with the inability to understand/follow study protocol
• Patients with pacemaker/AICD
• Non-native Ear/Previous scarring/surgical manipulation of ear
• Patients with contraindications to intra-op protocol
• Chronic pain patients
• Patients who have regularly used opioids for more than 6 weeks prior to surgery
• Patients with guages in their ears
• Patients who refuse to remove earrings/piercings prior to surgery
• Patients with nickel allergies (needles are made of nickel)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture + Standard of Care; Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen. Patients will have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally with electrostimulation at Shen men and Hypothalamus at 30 hz.	Other: Acupuncture + Standard of Care; Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan.
No Intervention: No acupuncture + Standard of Care; Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen. Patients will not have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blinding Assessment	Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.	postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating System (NRS) Pain at rest scores	Numerical rating score pain at rest on a scale of 0-10	postoperative day 1
Numerical Rating System (NRS) Pain with movement scores	Numerical rating score pain with movement on a scale of 0-10	postoperative day 1
Opioid Consumption	cumulative oral morphine equivalent	day of surgery through postoperative day 1

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Stephanie Cheng, MD, Hospital for Special Surgey

Publications and helpful links

General Publications

• Cheng SI, Norman RM, DeMeo D, Zhong H, Turteltaub LH, McCarthy MM, Marx RG, Strickland SM, Kelly AM. The Feasibility of Blinding Intraoperative Electro-Auricular Acupuncture Under Neuraxial Anesthesia. Med Acupunct. 2021 Aug 1;33(4):286-294. doi: 10.1089/acu.2021.0003. Epub 2021 Aug 17.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Acupuncture
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Leg Injuries; Knee Injuries; Pain, Postoperative; Wounds and Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 2018-1478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No