Post-operative Nausea and VomitingNCT01394536
Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
A study testing Battery-operated electroacustimulation device (Inactive) and Battery-operated electroacustimulation device (Active) in people with Post-operative Nausea and Vomiting, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Postoperative nausea and vomiting after outpatient surgery are significant sources of patient dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally as important as prevention of pain because both are large sources of patient dissatisfaction and can necessitate admission after… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Post-operative Nausea and Vomiting
- What is being tested?
- Battery-operated electroacustimulation device (Inactive) and Battery-operated electroacustimulation device (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for outpatient surgery procedure under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
Official title: The Effect of Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
Postoperative nausea and vomiting after outpatient surgery are significant sources of patient dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally as important as prevention of pain because both are large sources of patient dissatisfaction and can necessitate admission after routine outpatient procedures.
None of the currently available pharmacological interventions are able to totally abolish PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has yet to be studied when the patient takes the device home with them after leaving an outpatient facility.
Read the detailed description
The goal of this project is to perform a pilot study to determine if sending patients home with the electroacustimulation device will decrease their PONV and subsequently increase their overall satisfaction.
The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.
Secondary outcomes will be the amount of rescue nausea medications required by the patients, time to discharge, subjective pain assessment and the impact of their symptoms on the activities of daily living since being discharged from the surgery center based on survey, and amount of narcotic received.
This project would also aim to reduce the amount of time patients spend in recovery post-operatively, reduce hospital admissions secondary to persistent nausea and vomiting, and educate students and trainees about alternative methods of treating and preventing postoperative nausea and vomiting.
- Conditions
- Post-operative Nausea and Vomiting
- Being tested
- Battery-operated electroacustimulation device (Inactive), Battery-operated electroacustimulation device (Active)
- Keywords
- Post-operative, post-op, nausea, vomiting
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battery-operated electroacustimulation device (Inactive)Device
Also called ReliefBand
In the sham arm, this device will not be turned on. The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).
Battery-operated electroacustimulation device (Active)Device
Also called ReliefBand
The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | "Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive). Receives: Device: Battery-operated electroacustimulation device (Inactive) |
| 2 | Active comparator | The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device. Receives: Device: Battery-operated electroacustimulation device (Active) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of post-operative nausea and vomiting scores
The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.
Measured: 24 hours
Secondary outcomes (2)
Measure of amount of rescue nausea medications required
The amount of rescue nausea medications required by the patients, time to discharge, subjective pain assessment and the impact of their symptoms on the activities of daily living since being discharged from the surgery center based on survey, and amount of narcotic received.
Measured: 24 hours
Amount of time spent in recovery post-operatively
This project would also aim to reduce the amount of time patients spend in recovery post-operatively, reduce hospital admissions secondary to persistent nausea and vomiting, and educate students and trainees about alternative methods of treating and preventing postoperative nausea and vomiting.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
Why it stopped: The study was closed prior to enrollment of any subjects. No subjects were enrolled in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Marcus, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394536
- Sponsor's protocol ID
- H-2010-0063
- Status last verified
- Oct 2012
- First submitted
- 28 Jun 2011
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
- ClinicalTrials.gov ID
- NCT01394536
- Acronym / sponsor ID
- H-2010-0063
- Conditions
- Post-operative Nausea and Vomiting
- Keywords
- Post-operative, post-op, nausea, vomiting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was closed prior to enrollment of any subjects. No subjects were enrolled in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative nausea and vomiting after outpatient surgery are significant sources of patient dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally as important as prevention of pain because both are large sources of patient dissatisfaction and can necessitate admission after routine outpatient procedures.
None of the currently available pharmacological interventions are able to totally abolish PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has yet to be studied when the patient takes the device home with them after leaving an outpatient facility.
Detailed description
The goal of this project is to perform a pilot study to determine if sending patients home with the electroacustimulation device will decrease their PONV and subsequently increase their overall satisfaction.
The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.
Secondary outcomes will be the amount of rescue nausea medications required by the patients, time to discharge, subjective pain assessment and the impact of their symptoms on the activities of daily living since being discharged from the surgery center based on survey, and amount of narcotic received.
This project would also aim to reduce the amount of time patients spend in recovery post-operatively, reduce hospital admissions secondary to persistent nausea and vomiting, and educate students and trainees about alternative methods of treating and preventing postoperative nausea and vomiting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Device: Battery-operated electroacustimulation device (Inactive)"Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive). |
| 2 | Active comparator | Device: Battery-operated electroacustimulation device (Active)The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for outpatient surgery procedure under general anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battery-operated electroacustimulation device (Inactive)Also: ReliefBandIn the sham arm, this device will not be turned on. The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV). | Device | 1 |
| Battery-operated electroacustimulation device (Active)Also: ReliefBandThe device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV). | Device | 2 |
Primary outcome
Measure of post-operative nausea and vomiting scores
Time frame: 24 hours
The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.
2 secondary outcomes
Measure of amount of rescue nausea medications required
Time frame: 24 hours
Amount of time spent in recovery post-operatively
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Marcus, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battery-operated electroacustimulation device (Inactive) and Battery-operated electroacustimulation device (Active) in people with Post-operative Nausea and Vomiting, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of post-operative nausea and vomiting scores (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.