The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients

NCT00941005 | Completed Results FDA Device

• 1 other identifier: H-2007-0100
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (5)

• 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.

  24 hours

• Incidence of Post-operative Emetic Events

  24 hours

• Number of Participants With Post-operative Need for Rescue Medications

  24 hours

• Time to Participant Discharge

  24 hours

• 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.

  24 hours post-op

Secondary Outcomes (2)

• Postoperative Pain Scores

  24 hours

• Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op

  24 hours post-op

Study Arms (2)

Electroacustimulation

EXPERIMENTAL

Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.

Device: Electroacustimulation

Control

SHAM COMPARATOR

Received a device that was not turned on.

Device: Electroacustimulation

Interventions

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.

Also known as: ReliefBand (Aeromedix, Jackson, WY)

Control; Electroacustimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing surgery at the University of Wisconsin outpatient surgery center

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Transformations Surgery Center

Middleton, Wisconsin, 53719, United States

Location

Related Publications (2)

• 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.

  PMID: 15385352 BACKGROUND

• 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.

  PMID: 20195124 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Limitations and Caveats

Raw data from which to report summary results no longer exist for this study. Outcomes were published and the data were represented in graphs. We have done our due diligence to populate this record with data provided in the publication.

Results Point of Contact

• Title: Jeffrey Larson, MD
• Organization: University of Wisconsin - Madison

larsonjef@surgery.wisc.edu

(608) 417-6175

Study Officials

• Karol A Gutowski, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Locations

US (1)