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Procedure

Electrical Stimulation for Post-Operative Nausea and Vomiting

N/A

Waitlist Available

Led By Alicia M. Kowalski, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of patient reported PONV, CINV or motion sickness

Female gender

Must not have

Local skin infections at or near the acustimulation site

Surgery that would not allow access to at least one P6 site.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether electrical stimulation during surgery is a feasible way to reduce pain for women having breast surgery.

Who is the study for?

This trial is for adult women who have experienced nausea or vomiting after surgery, chemotherapy, or due to motion sickness. They must be scheduled for breast surgery and able to give informed consent. It's not suitable for those with certain medical conditions like severe upper limb deformities, bowel obstruction, pacemakers, pre-existing nausea/vomiting, CNS disorders causing weakness/paresis in limbs, metal implants in the treatment area, pregnancy, skin infections near the stimulation site or substance abuse.

What is being tested?

The study tests if light electrical stimulation at a wrist point during breast surgery can prevent post-operative nausea and vomiting (PONV). Participants will also receive standard anti-nausea medications such as Phenergan (promethazine), Zofran (ondansetron), Dexamethasone and Pepcid (famotidine) alongside completing questionnaires about their symptoms.

What are the potential side effects?

Possible side effects from the electrical stimulation may include discomfort at the wrist site. Standard medications used like Phenergan can cause drowsiness; Zofran might lead to headaches; Dexamethasone could result in increased appetite; Pepcid generally has fewer side effects but may sometimes cause fatigue or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced nausea or vomiting from motion, chemotherapy, or anesthesia.

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I am female.

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I am scheduled for breast surgery.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin infection near where a device would be placed on my skin.

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I can have acupuncture on at least one P6 site after surgery.

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I needed medication for nausea or vomiting more than 3 times last week.

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I have had a stroke or brain disorder that caused weakness on the opposite side of my disease.

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I have severe nerve damage in my arms or hands.

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I do not have a cardiac pacemaker.

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I have a blockage in my intestines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of Electrical Stimulation of P6 Combined with Prophylactic Anti-Emetics Versus Pharmacological Prophylaxis Alone in Preventing the Incidence of Post-Operative Nausea and Vomiting (PONV)

Secondary study objectives

Feasibility of Intraoperative Neuromuscular Blockade Monitor (NMBM) During Surgery for Breast Cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Electrical Stimulation + Standard of Care AntiemeticsExperimental Treatment6 Interventions

Participants receive light electrical stimulation to the wrist area during surgery. Participants also receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Group II: Standard of Care AntiemeticsActive Control5 Interventions

Participants receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zofran

2016

Completed Phase 4

~860

Electrical Stimulation

2013

Completed Phase 3

~640