NCT03187535

Effect of TEAS on PONV After Spinal Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Jyoti Pandya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PONV

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2026-11-20
• Completion: 2026-12-20
• First posted: 2017-06-15
• Last updated: 2025-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study