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

Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Blinding Assessment

Secondary Outcome

 Numerical Rating System (NRS) Pain at rest scores

Condition

ACL

Intervention

Acupuncture + Standard of Care

Study Arms / Comparison Groups

 Acupuncture + Standard of Care
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

40

Start Date

November 1, 2018

Completion Date

December 13, 2019

Primary Completion Date

December 13, 2019

Eligibility Criteria

        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)
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Stephanie Cheng, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03711734

Organization ID

2018-1478


Responsible Party

Sponsor

Study Sponsor

Hospital for Special Surgery, New York


Study Sponsor

Stephanie Cheng, MD, Principal Investigator, Hospital for Special Surgey


Verification Date

February 2020