Effect of TEAS on PONV After Spinal Surgery

PONV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03187535
• Other study ID #: 2017H0101
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 20, 2024

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Juan Fiorda, MD, PhD
• Phone: 614-293-3559
• Email: juan.fiorda[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 20, 2024
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• PONV

Intervention

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.

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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jyoti Pandya

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of PONV	measure the incidence of PONV in spinal surgery	up to 24 hours after surgery
Primary	severity of PONV	use Verbal Rating Scale (VRS) score (0-10) to rate nausea	up to 24 hours after surgery
Secondary	Time to first nausea/vomiting rescue medication	Time until subject requests rescue anti-emetic therapy	within 2 and 24 hours after surgery
Secondary	opioid consumption (units of morphine equivalence)	compare the opioid consumption after surgery in units of morphine	2 and 24 hours after surgery
Secondary	incidence of adverse events	compare incidence of adverse events between groups	24 hours after surgery