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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941005

Enrollment

122

Registered

2009-07-17

Start date

2008-01-31

Completion date

2008-12-31

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

DEVICEElectroacustimulation

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Post-operative Emetic Events	24 hours	—
Time to Participant Discharge	24 hours	—
Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op	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.
Post-operative Nausea Scores	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.
Number of Participants With Post-operative Need for Rescue Medications	24 hours	—

Secondary

Measure	Time frame	Description
Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op	24 hours post-op	Phone survey of post-op pain medication usage was administered on postoperative day 1.
Postoperative Pain Scores	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Electroacustimulation Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures. Electroacustimulation: 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.	61
Control Sham electroacustimulation device (turned off) Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery	61
Total	122

Baseline characteristics

Characteristic	Electroacustimulation	Control	Total
Age, Customized Data no longer exists	NA participants	NA participants	NA participants
Region of Enrollment United States	61 participants	61 participants	122 participants
Sex: Female, Male Female	NA Participants	NA Participants	NA Participants
Sex: Female, Male Male	NA Participants	NA Participants	NA Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0