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

Primary Purpose

Tonsillitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular acupuncture
Sponsored by
Defense and Veterans Center for Integrative Pain Management
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis focused on measuring auricular, acupuncture, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Womack Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1 - Receives auricular acupuncture

Group 2 don't receive anything

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
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.
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.

Full Information

First Posted
October 2, 2015
Last Updated
May 27, 2020
Sponsor
Defense and Veterans Center for Integrative Pain Management
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1. Study Identification

Unique Protocol Identification Number
NCT02571075
Brief Title
Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea
Acronym
BFA
Official Title
A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
August 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Defense and Veterans Center for Integrative Pain Management

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis
Keywords
auricular, acupuncture, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Receives auricular acupuncture
Arm Type
Experimental
Arm Description
Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.
Arm Title
Group 2 don't receive anything
Arm Type
No Intervention
Arm Description
They do not receive any any acupuncture only standard of care.
Intervention Type
Other
Intervention Name(s)
Auricular acupuncture
Other Intervention Name(s)
"Battlefield Acupuncture" BFA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Scores
Description
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.
Time Frame
10 days after the procedure.
Title
The Morphine Equivalent of Opioid Use
Description
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.
Time Frame
Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.
Secondary Outcome Measure Information:
Title
Return to Diet
Description
Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)
Time Frame
Within 10 days post operatively
Title
Number of Participants With Nausea Post Operatively
Description
It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.
Time Frame
1-3 hours postoperativey
Title
Number of Participants With Nausea Post Operatively
Description
It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.
Time Frame
1-3 hours post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony R Plunkett, MD
Organizational Affiliation
Womack Army Medical Center Fort Bragg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States

12. IPD Sharing Statement

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

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