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

Study Overview
=================
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.

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

Conditions
-----------------
ACL, ACL Injury, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Anesthesia

Intervention / Treatment
-----------------
* Other: Acupuncture + Standard of Care


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture + Standard of Care<br>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<br>* 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.<br>|
| No Intervention: No acupuncture + Standard of Care<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture