Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea

Study Overview
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Brief Summary
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The purpose of this study is to determine if auricular acupuncture significantly reduces post-operative pain in comparison to the standard of care. Post-operative pain score will be collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst imaginable pain) up to 10 days post-operation.

Detailed Description
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DESIGN: Design type: Prospective, randomized control trial Sample Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study. Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects. Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.

Official Title
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A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults

Conditions
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Tonsillitis

Intervention / Treatment
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* Other: Auricular acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All adults eighteen years of age or older having a tonsillectomy with or without adenoidectomy Anesthesiologist classification one to three Exclusion Criteria Chronic pain syndromes or pain symptoms lasting greater than three months or taking opioids on a daily basis for greater than four months Anesthesiologist classification four Prior neck or throat surgery Allergy to gold

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Receives auricular acupuncture<br>Receives Battlefield Acupuncture (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened. | Other: Auricular acupuncture<br>* The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin.<br>* Other names: Battlefield Acupuncture BFA;|
| No Intervention: Group 2 don't receive anything<br>They do not receive any any acupuncture only standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not. | 10 days after the procedure. | 
| The Morphine Equivalent of Opioid Use | The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period. | Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to Diet | Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them) | Within 10 days post operatively | 
| Number of Participants With Nausea Post Operatively | It will be documented yes or no if the participant voiced any complaint of nausea while in recovery. | 1-3 hours postoperativey | 
| Number of Participants With Nausea Post Operatively | It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home. | 1-3 hours post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auricular, acupuncture, pain