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