Clinical trial NCT00941005: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Post-operative Nausea Scores
timeFrame: 24 hours
measure: Incidence of Post-operative Emetic Events
timeFrame: 24 hours
measure: Number of Participants With Post-operative Need for Rescue Medications
timeFrame: 24 hours
measure: Time to Participant Discharge
timeFrame: 24 hours
measure: Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op
timeFrame: 24 hours post-op
Secondary outcomes:
measure: Postoperative Pain Scores
timeFrame: 24 hours
measure: Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op
timeFrame: 24 hours post-op
Other outcomes:
Locations:
city: Middleton
country: United States
facility: Transformations Surgery Center
state: Wisconsin
Study officials:
affiliation: Endeavor Health
name: Karol A Gutowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.