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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacustimulation | Experimental | Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device. |
|
| Control | Sham Comparator | Received a device that was not turned on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karol A Gutowski, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transformations Surgery Center | Middleton | Wisconsin | 53719 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15385352 | Background | 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. | |
| 20195124 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Sham electroacustimulation device (turned off) Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. | Posted | Number | participants | 24 hours |
|
up to 24 hours post-operatively
Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. There is no evidence that Adverse Events Data was monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Larson, MD | University of Wisconsin - Madison | (608) 417-6175 | larsonjef@surgery.wisc.edu |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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|
Phone survey of post-op pain medication usage was administered on postoperative day 1. |
| 24 hours post-op |
| BG001 | Control | Sham electroacustimulation device (turned off) Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control |
Sham electroacustimulation device (turned off) Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery |
|
|
| Primary | Incidence of Post-operative Emetic Events | Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. | Posted | Mean | Standard Error | incidence of emetic events | 24 hours |
|
|
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| Primary | Number of Participants With Post-operative Need for Rescue Medications | Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Primary | Time to Participant Discharge | Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. | Posted | Mean | Standard Error | minutes | 24 hours |
|
|
|
| Primary | 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. | Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. | Posted | Mean | Standard Error | score on a scale | 24 hours post-op |
|
|
|
| Secondary | 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. | Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. | Posted | Mean | Standard Error | score on a scale | 24 hours |
|
|
|
| Secondary | 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. | Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. | Posted | Count of Participants | Participants | 24 hours post-op |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Sham electroacustimulation device (turned off) Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| 120 min post-op |
|