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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Fiorda, MD, PhD | Contact | 614-293-3559 | juan.fiorda@osumc.edu | |
| Alberto Uribe, MD | Contact | 614-293-3559 | alberto.uribe@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sergio Bergese, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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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.
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| 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. |
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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 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |