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

Defense and Veterans Center for Integrative Pain Management

Status: Completed

Conditions: Tonsillitis

Treatments: Other: Auricular acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02571075

381600

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 2 patient groups

Group 1 - Receives auricular acupuncture

Experimental group

Description:

Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.

Treatment:

Other: Auricular acupuncture

Group 2 don't receive anything

No Intervention group

Description:

They do not receive any any acupuncture only standard of care.