The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroacustimulation
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility Criteria
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
Sites / Locations
- Transformations Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Electroacustimulation
Control
Arm Description
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.
Received a device that was not turned on.
Outcomes
Primary Outcome Measures
Post-operative Nausea Scores
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.
Incidence of Post-operative Emetic Events
Number of Participants With Post-operative Need for Rescue Medications
Time to Participant Discharge
Phone Survey of Nausea / Vomiting Symptoms 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.
Secondary Outcome Measures
Postoperative Pain Scores
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.
Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op
Phone survey of post-op pain medication usage was administered on postoperative day 1.
Full Information
NCT ID
NCT00941005
First Posted
July 15, 2009
Last Updated
August 12, 2020
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00941005
Brief Title
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
Official Title
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients: A Prospective, Randomized, Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electroacustimulation
Arm Type
Experimental
Arm Description
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Received a device that was not turned on.
Intervention Type
Device
Intervention Name(s)
Electroacustimulation
Other Intervention Name(s)
ReliefBand (Aeromedix, Jackson, WY)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative Nausea Scores
Description
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.
Time Frame
24 hours
Title
Incidence of Post-operative Emetic Events
Time Frame
24 hours
Title
Number of Participants With Post-operative Need for Rescue Medications
Time Frame
24 hours
Title
Time to Participant Discharge
Time Frame
24 hours
Title
Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op
Description
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.
Time Frame
24 hours post-op
Secondary Outcome Measure Information:
Title
Postoperative Pain Scores
Description
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.
Time Frame
24 hours
Title
Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op
Description
Phone survey of post-op pain medication usage was administered on postoperative day 1.
Time Frame
24 hours post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karol A Gutowski, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transformations Surgery Center
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15385352
Citation
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.
Results Reference
background
PubMed Identifier
20195124
Citation
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.
Results Reference
result
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The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
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