Effect of TEAS on PONV After Spinal Surgery

NCT03187535 | Recruiting FDA Device

• 1 other identifier: 2017H0101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

PONV

Keywords

Transcutaneous Electrical Acupoint Stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Time to first nausea/vomiting rescue medication

  within 2 and 24 hours after surgery

• opioid consumption (units of morphine equivalence)

  2 and 24 hours after surgery

• incidence of adverse events

  24 hours after surgery

Study Arms (2)

Transcutaneous Electrical Acupoint Stimulation

EXPERIMENTAL

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

No Transcutaneous Electrical Acupoint Stimulation

SHAM COMPARATOR

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

Interventions

TEAS via ES-130 DEVICE

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.

Transcutaneous Electrical Acupoint Stimulation

No TEAS OTHER

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.

No Transcutaneous Electrical Acupoint Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jyoti Pandya: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Sergio Bergese, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Fiorda, MD, PhD

CONTACT

614-293-3559; juan.fiorda@osumc.edu

Alberto Uribe, MD

CONTACT

614-293-3559; alberto.uribe@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant will be blinded to the treatment arm; all investigators and care providers will be blinded to the treatment arm. Only the anesthesiologist trained in acupuncture and administering the treatment will know the randomization group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Principal Investigatgor, Associate Attending

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: June 15, 2017
• Study Start: August 1, 2018
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)