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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Group 1 - Receives auricular acupuncture	Auricular acupuncture	Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.

Primary Outcome Measures

Name	Time	Method
The Morphine Equivalent of Opioid Use	Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.	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.
Pain Scores	10 days after the procedure.	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.

Secondary Outcome Measures

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