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

Ketamine

Brief Summary

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.

Intervention / Treatment

  • Acupuncture + Standard of Care (OTHER)
    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.

Condition or Disease

  • ACL
  • ACL Injury
  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Rupture
  • Anesthesia

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 12 Years and older   (Child, Adult, Older Adult)
    Enrollment: 40 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 01, 2018 ACTUAL
    Primary Completion: Dec 13, 2019 ACTUAL
    Completion Date: Dec 13, 2019 ACTUAL
    Study First Posted: Oct 18, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 08, 2020

    Sponsors / Collaborators

    Lead Sponsor: Hospital for Special Surgery, New York
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New York, New York, USA

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 12
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    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)

    Primary Outcomes

    • 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.

    Secondary Outcomes

    • Numerical rating score pain at rest on a scale of 0-10

    • Numerical rating score pain with movement on a scale of 0-10

    • cumulative oral morphine equivalent

    More Details

    NCT Number: NCT03711734
    Other IDs: 2018-1478
    Study URL: https://clinicaltrials.gov/study/NCT03711734
    Last updated: Sep 29, 2023