- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00941005
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients: A Prospective, Randomized, Blinded Clinical Trial
Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has been demonstrated to be effective in controlling these symptoms, but trials identifying their efficacy in the outpatient surgery population are lacking. This study integrates conventional pharmacotherapy with alternative medicine in prevention of PONV.
Materials and Methods: One hundred twenty two patients undergoing surgery procedures at an outpatient surgery center were randomized to two treatment arms. The first arm was standardized pharmacologic PONV prevention typical for patients undergoing outpatient surgery, while the second arm employed the use of ReliefBand, an FDA-approved electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms, emetic events, the need for rescue medications and the time to discharge.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Middleton, Wisconsin, United States, 53719
- Transformations Surgery Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- undergoing surgery at the University of Wisconsin outpatient surgery center
Exclusion Criteria:
- pregnancy
- currently experiencing menstrual symptoms
- cardiac pacemaker
- previous experience with acupuncture therapy
- pharmacologic treatment for nausea or vomiting in the 24 hours prior to surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electroacustimulation
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.
|
Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
Other Names:
|
Sham Comparator: Control
Received a device that was not turned on.
|
Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Nausea Scores
Time Frame: 24 hours
|
Nausea is scored on a scale of 1-10 where 1 is least nauseated and 10 is severely nauseated.
Nausea scores will be collected 30, 60, and 120 minutes after surgery.
|
24 hours
|
Incidence of Post-operative Emetic Events
Time Frame: 24 hours
|
24 hours
|
|
Number of Participants With Post-operative Need for Rescue Medications
Time Frame: 24 hours
|
24 hours
|
|
Time to Participant Discharge
Time Frame: 24 hours
|
24 hours
|
|
Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op
Time Frame: 24 hours post-op
|
Phone survey of nausea/vomiting symptoms was administered on postoperative day 1.
The survey consists of 8 questions, including: 1) a query about whether or not participant has experienced nausea since returning home; 2) rate nausea severity on a scale of 1-10 (where 10 is the most severe); 3) a query about satisfaction of nausea control; 4) a question asking if they would use the same post-op nausea treatment again; 5) a query about what activities the participant has been unable to do since surgery; 6) whether or not the participant has taken prescription medicine for treatment of nausea since returning home; 7) whether or not participant has taken prescription medicine for treatment of pain since returning home; and 8) if yes for 6-7, which medications.
|
24 hours post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Pain Scores
Time Frame: 24 hours
|
Participants will evaluate their postoperative pain score on a scale of 1-10 where 1 is the least pain and 10 is the most severe pain.
Pain scores will be evaluated at 30, 60, and 120 minutes postop.
|
24 hours
|
Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op
Time Frame: 24 hours post-op
|
Phone survey of post-op pain medication usage was administered on postoperative day 1.
|
24 hours post-op
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karol A Gutowski, MD, NorthShore University HealthSystem
Publications and helpful links
General Publications
- Gan TJ, Jiao KR, Zenn M, Georgiade G. A randomized controlled comparison of electro-acupoint stimulation or ondansetron versus placebo for the prevention of postoperative nausea and vomiting. Anesth Analg. 2004 Oct;99(4):1070-1075. doi: 10.1213/01.ANE.0000130355.91214.9E.
- Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
Study record dates
Study Major Dates
Study Start
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2007-0100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Postoperative Nausea and Vomiting
-
Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
-
MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
-
Methodist Health SystemRecruitingNausea, Postoperative | Vomiting, PostoperativeUnited States
-
Yeungnam University College of MedicineCompletedPostoperative Nausea | Postoperative VomitingKorea, Republic of
-
Northwell HealthTerminatedPostoperative Pain | Postoperative Nausea | Postoperative VomitingUnited States
-
Hôpital Privé de Parly II - Le ChesnayCompletedPostoperative Nausea | Postoperative Vomiting | Postoperative EmesisFrance
-
Vestre VikenHF Kongsberg SykehusNorwegian Medical AssociationCompletedPostoperative Complications | Postoperative Pain | Postoperative Vomiting and Nausea | Mental Status Changes PostoperativeKazakhstan, Russian Federation
-
Oregon Health and Science UniversityCompletedPostoperative Vomiting and NauseaUnited States
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Hungary, Canada, Spain, Belgium, Germany
Clinical Trials on Electroacustimulation
-
University of Wisconsin, MadisonWithdrawnPost-operative Nausea and VomitingUnited States