Effect of TEAS on PONV After Spinal Surgery

Study Overview
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Brief Summary
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The proposed research will utilize electroacupuncture, a type of needleless acupuncture that uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.

Detailed Description
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The rates of PONV will be evaluated over the first 24 hours after surgery, opioid consumption in units of morphine equivalence, and any adverse side effects will be recorded. Subjects who are included in the research will be randomly assigned to one of two groups - one group is the control group, receiving no TEAS, and the other group receiving TEAS. An anesthesiologist trained in acupuncture will utilize the Excel Pointer to locate the specific acupoints previously identified as associated with prevention PONV. Anesthesiologist will place electrocardiogram (ECG) pads at the identified acupoints prior to surgery. Subjects will be connected to the ES-130 (electro-therapy) device upon entering the operating room. Prior to the surgical closure, the unblinded researcher will initiate delivery of TEAS, or not, according to study protocol based on the randomization group of the participant. The anesthesiologist will not know the group assignment. At the end of surgery, the subject will be disconnected from the ES-130 and the ECG pads will be carefully removed. Researchers will follow up with the subject in recovery regarding any occurrence and severity of PONV, adverse events, and verbal pain scores, until 24 hours after end of surgery.

Official Title
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The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery

Conditions
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PONV

Intervention / Treatment
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* Device: TEAS via ES-130
* Other: No TEAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients , 18 or older American Society of Anesthesiologists (ASA) classification I or II or III Undergoing elective spinal surgery expected to last no more than four hours (from induction of anesthesia to extubation). Capable and willing to consent Exclusion Criteria: Neuraxial (intrathecal or epidural) block Significant ongoing history of vestibular disease or dizziness Nausea or vomiting within 24 hours prior to surgery, use of antiemetic or emetogenic drugs within 3 days of surgery Documented alcohol or substance abuse within 3 months before the surgery Limb abnormalities such as burn and amputation. Poorly controlled diabetes mellitus (fasting plasma glucose >126 mg/dL or <70 mg/dL) Implantation of metal/electrical devices, such as nerve stimulator, cardiac pacemaker, cardioverter, defibrillator and internal hearing aids Rash, local infection, keloid, any dermatologic condition that could interfere with the acupoint stimulation area Documented alcohol or substance abuse within 3 months before surgery Presence of clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, or schizophrenia Chemotherapy or radiation therapy within 7 days before surgery Investigational product use within 3 months prior surgery Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study (history of unstable cardiovascular, pulmonary, renal, hepatic, seizures) Special population (prisoners, pregnant and lactating women)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Electrical Acupoint Stimulation<br>Subjects in the Transcutaneous Electrical Acupoint Stimulation (TEAS) group will receive 20 minutes of TEAS via ES-130 beginning at the time ondansetron is administered (usually given 30 minutes before the end of surgery), for prevention of PONV. | Device: TEAS via ES-130<br>* Transcutaneous Electrical Acupoint Stimulation will be administered delivered by the ES-130 device for 20 minutes at the time ondansetron is given (typically 30 minutes before the end of surgery). Subjects randomized to this intervention will have the TEAS device connected to the previously placed ECG patches to deliver the stimulus.<br>|
| Sham Comparator: No Transcutaneous Electrical Acupoint Stimulation<br>Subjects in the No Transcutaneous Electrical Acupoint Stimulation group will not receive any TEAS, although they will have the acupoints identified and ECG patches placed. The device will not be connected to the electrodes of the ES-130 device at the end of surgery, and no TEAS will be delivered. | Other: No TEAS<br>* No Transcutaneous Electrical Acupoint Stimulation will be delivered to the subjects randomized to this group; ECG patches will be placed at the identified acupoints, however, no electrical stimulus will be delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of PONV | measure the incidence of PONV in spinal surgery | up to 24 hours after surgery | 
| severity of PONV | use Verbal Rating Scale (VRS) score (0-10) to rate nausea | up to 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first nausea/vomiting rescue medication | Time until subject requests rescue anti-emetic therapy | within 2 and 24 hours after surgery | 
| opioid consumption (units of morphine equivalence) | compare the opioid consumption after surgery in units of morphine | 2 and 24 hours after surgery | 
| incidence of adverse events | compare incidence of adverse events between groups | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous Electrical Acupoint Stimulation