Effect of TEAS on PONV After Spinal Surgery

Not Applicable

Recruiting

• Conditions: PONV
• Interventions: Device: TEAS via ES-130; Other: No TEAS

• Registration Number: NCT03187535
• Lead Sponsor: Jyoti Pandya

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-15
• Study Start: 2018-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-11-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous Electrical Acupoint Stimulation	TEAS via ES-130	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.
No Transcutaneous Electrical Acupoint Stimulation	No TEAS	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States