Effect of TEAS on PONV After Spinal Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: PONV
• Intervention / Treatment: Device: TEAS via ES-130; Other: No 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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Fiorda, MD, PhD; Phone Number: 614-293-3559; Email: juan.fiorda@osumc.edu
• Study Contact Backup: Name: Alberto Uribe, MD; Phone Number: 614-293-3559; Email: alberto.uribe@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Juan Fiorda, MD; Phone Number: 614-293-3559; Email: juan.fiorda@osumc.edu
      • Contact: Sergio D Bergese, MD; Phone Number: 614-293-3559; Email: Sergio.Bergese@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Electrical Acupoint Stimulation; 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; 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.
Sham Comparator: No Transcutaneous Electrical Acupoint Stimulation; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jyoti Pandya
• Investigators: Principal Investigator: Sergio Bergese, MD, The Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): November 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Transcutaneous Electrical Acupoint Stimulation
• Other Study ID Numbers: 2017H0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No