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Effect of TEAS on PONV After Spinal Surgery

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ClinicalTrials.gov Identifier: NCT03187535
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sergio Bergese, Ohio State University

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.

Condition or disease Intervention/treatment Phase
PONV Device: TEAS via ES-130 Other: No TEAS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. incidence of PONV [ Time Frame: up to 24 hours after surgery ]
    measure the incidence of PONV in spinal surgery

  2. severity of PONV [ Time Frame: up to 24 hours after surgery ]
    use Verbal Rating Scale (VRS) score (0-10) to rate nausea


Secondary Outcome Measures :
  1. Time to first nausea/vomiting rescue medication [ Time Frame: within 2 and 24 hours after surgery ]
    Time until subject requests rescue anti-emetic therapy

  2. opioid consumption (units of morphine equivalence) [ Time Frame: 2 and 24 hours after surgery ]
    compare the opioid consumption after surgery in units of morphine

  3. incidence of adverse events [ Time Frame: 24 hours after surgery ]
    compare incidence of adverse events between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187535


Contacts
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Contact: Nicoleta Stoicea, MD, PhD 614-293-0775 nicoleta.stoicea@osumc.edu
Contact: Sergio Bergese, MD 614-293-3559 sergio.bergese@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sergio D Bergese, MD    614-293-3559    Sergio.Bergese@osumc.edu   
Contact: Nicoleta Stoicea, MD, PhD    614-293-0775    nicoleta.stoicea@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Sergio Bergese, MD The Ohio State University Wexner Medical Center

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Responsible Party: Sergio Bergese, Section Director, Neurosurgical Anesthesiology Services, Ohio State University
ClinicalTrials.gov Identifier: NCT03187535     History of Changes
Other Study ID Numbers: 2017H0101
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sergio Bergese, Ohio State University:
Transcutaneous Electrical Acupoint Stimulation

Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting