- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269345
Auricular Acupuncture in Ureteral Stent Pain (AAstent)
Auricular Acupuncture: A Novel Application in Ureteral Stent Pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will be ages 18 years or older and scheduled for routine urologic surgery. To randomize subjects, the investigators will employ a random number generator, which will minimize difference between study groups.
Screening Visit:
Obtain signed Informed Consent document and HIPAA Authorization. Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital signs review, medication list, co-morbidities, prior surgical history, demographics, problems list, and note any prior acupuncture received.
Subjects will be given a Medication Log to assist them in documenting the amount of pain medications that they are taking as part of standard of care.
Subjects will be given a handout of standard BFA Discharge Instructions including what an infection looks like and what to do in the event of an infection (see attached).
Visit 1 (Baseline):
Subjects will be randomized into 1 of 2 groups:
Group 1: Standard operative and standard post-operative care plus BFA (up to 5 acupuncture needles* in each ear at points cingulate gyrus, thalamus, omega 2, shen-men, point zero, identified by point-finder) Group 2: Standard treatment alone. Subjects will be given treatment according to their randomization group. The investigators review the subject's medical record and document any standard of care pain assessments that were performed upon admission and after pain intervention to the Post Anesthesia Care Unit (PACU) and Same Day Surgery Unit (SDSU). The investigators will also record the amounts of standard of care pain medications used during their hospital stay.
All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 24 hours after Visit 1.
Ear Acupuncture needles will fall out on their own within about one week.
Visit #2 (24 hours post-surgery):
Subject will be contacted in-person, via phone, email, or text message asked:
On a scale of 0-10, with 10 being the worst pain, what is their pain level? Have they returned to work or resumed normal household duties? If so, how many hours post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? Essentris electronic inpatient medical record will be reviewed to determine total dose of pain medications received if still in hospital.
Is the patient voiding without irritative symptoms? Urinary frequency, urgency, dysuria, hematuria will be assessed.
Visit #3 (48 hours post- surgery)
Subject will be contacted either in-person, or via phone, email or text message and asked:
On a scale of 0-10, with 10 being the worst pain, what is their level of pain? Have they returned to work or resumed normal household duties? If so, how many hours post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? Essentris electronic inpatient medical record will be reviewed to determine total dose of pain medications received if still in hospital.
Is the patient voiding without irritative symptoms? Urinary frequency, urgency, dysuria, hematuria will be assessed.
Visit #4 (1 week post-surgery)
Subject will be contacted either in-person, or via phone, email or text message and asked:
Have they returned to work or resumed normal household duties? If so, how many days post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? USSQ (Stent in Situ) will be administered to patients.
Visit #5 Visit (1 month post surgery with stent in-situ or 5 weeks post stent removal at week 1)
Subject will be contacted either in-person, or via phone, email or text message and asked:
Have they returned to work or resumed normal household duties? If so, how many days post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? USSQ (Post Stent) will be administered to patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Nellis Air Force Base, Nevada, United States, 89191
- Mike O'Callaghan Federal Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion:
- Male and female DoD beneficiaries
- Age 18 years or older who are scheduled for elective urologic surgery that would be expected to have the routine placement of a ureteral stent (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone, extracorporeal stone wave lithotripsy (ESWL) of stone greater than 10mm).
Exclusion:
- Pregnant or breastfeeding.
- Traumatic ureteral injury repairs with stents.
- Ureteral stents placed during procedures for urologic cancer treatments.
- Sepsis prior to stent placement or other active urologic infection.
- Absence of ear.
- Active cellulitis of ear.
- Ear anatomy precluding identification of acupuncture landmarks.
- Non-English speaking.
- Use of Hearing Aids that preclude the insertion of ASP needles.
- Inability to comply with study protocol.
- Patients receiving treatment for chronic pain conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Battlefield Acupuncture
BFA at points cingulate gyrus, thalamus, omega 2, shen-men, point zero
|
Battlefield Acupuncture at points cingulate gyrus, thalamus, omega 2, shen-men, point zero
|
PLACEBO_COMPARATOR: Standard Treatment
Standard Treatment alone
|
Standard Treatment alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improved ability to tolerate the presence of the ureteral stent
Time Frame: 1 month
|
This will be assessed via the Ureteric Stent Symptoms Questionnaire
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reduce narcotic use
Time Frame: 1 month
|
We will ask the participant during each visit what pain medication are they taking?
And what strength?
How many total doses have they taken since their surgery?
|
1 month
|
post-operative readmission rates for pain/irritative symptoms
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FWH20140088H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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