Overview

Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)

Status:
Active, not recruiting
Trial end date:
2022-08-31
Target enrollment:
0
Participant gender:
Female
Summary
The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Antiemetics
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Diphenhydramine
Famotidine
Ondansetron
Promethazine
Criteria
Inclusion Criteria:

1. Adults at least 18 years of age

2. Female gender

3. History of patient reported PONV, CINV or motion sickness

4. Patients scheduled for Breast Surgery

5. Sign an informed consent indicating they are aware of the investigational nature of
this study.

Exclusion Criteria:

1. Patients scheduled for paravertebral block

2. Upper extremity deformity contralateral to the site of disease that could interfere
with accurate point location or alter the energy pathway as defined by traditional
acupuncture theory

3. Local skin infections at or near the acustimulation site

4. Pre-existing nausea and vomiting, defined as nausea or vomiting requiring
pharmacological treatment greater than 3 times in the week preceding screening

5. History of CVA or other central nervous system disorder resulting in residual weakness
or paresis of extremity contralateral to the site of disease

6. Grade III or IV upper extremity peripheral neuropathy

7. Cardiac pacemakers. Patients involved in this protocol will receive electrical
stimulation. For safety reasons, electrical stimulation should be avoided in patients
with pacemakers

8. Metal implants for the treatment extremity. For safety reasons, use of electrical
stimulation should be avoided

9. Current acknowledged use of any illicit drugs, medical marijuana (including Marinol),
or evidence of alcohol abuse as defined by The American Psychiatric Association
criteria. This includes patients who are currently in the recovery process.

10. Pregnancy as this would alter anesthesia plan

11. Bowel obstruction

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