Expired Study
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Fort Bragg, North Carolina 28310


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02571075


Primary Contact:

Principal Investigator
Anthony R Plunkett, MD
Womack Army Medical Center Fort Bragg


Backup Contact:

N/A


Location Contact:

Fort Bragg, North Carolina 28310
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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