TEAS for Postoperative Nausea and Vomiting

Overseen By Alberto Uribe, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jyoti Pandya

Must not be taking: Antiemetics, Emetogenics

Disqualifiers: Vestibular disease, Diabetes, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use anti-nausea or nausea-inducing drugs within 3 days before surgery.

What data supports the effectiveness of the treatment TEAS for postoperative nausea and vomiting?

Research shows that transcutaneous electrical acupoint stimulation (TEAS) is effective in preventing postoperative nausea and vomiting after general anesthesia, according to a meta-analysis of randomized controlled trials. ^{1 2 3 4 5}

Is transcutaneous electrical acupoint stimulation (TEAS) safe for humans?

The research does not provide specific safety data for TEAS, but it is generally considered a non-invasive and low-risk treatment, similar to acupuncture, which is often used for various conditions. ^{1 3 6 7 8}

How does the treatment TEAS for postoperative nausea and vomiting differ from other treatments?

TEAS (Transcutaneous Electrical Acupoint Stimulation) is unique because it uses electrical stimulation on specific acupoints on the skin to help manage nausea and vomiting after surgery, unlike traditional medications that are taken orally or intravenously. This method is non-invasive and may offer an alternative for patients who prefer not to use drugs or have difficulty with medication side effects. ^{9 10 11 12 13}

Research Team

Sergio Bergese, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for men and women over 18, with an ASA classification I-III, undergoing elective spinal surgery lasting no more than four hours. Participants must be able to consent. Excluded are those with certain medical conditions like vestibular disease, recent nausea or drug use, poorly controlled diabetes, metal/electrical implants, skin issues at the stimulation site, major psychiatric conditions, recent chemo/radiation therapy or investigational product use.

Inclusion Criteria

My health is good to moderate, with or without severe systemic disease.

I am able and willing to agree to participate.

I am scheduled for a spinal surgery that will last less than 4 hours.

Exclusion Criteria

Documented alcohol or substance abuse within 3 months before the 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)

My blood sugar levels are not well-controlled.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo spinal surgery with or without TEAS, with monitoring of PONV and opioid consumption

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for PONV, opioid consumption, and adverse events for 24 hours post-surgery

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• TEAS

Trial Overview The study tests if TEAS (a needleless acupuncture using electrostimulation) can reduce post-operative nausea and vomiting in patients after spinal surgery compared to a group without TEAS. It's a randomized double-blind trial meaning participants are randomly assigned to groups and neither they nor the researchers know who receives which treatment until after the results are collected.

Participant Groups

Group I: Transcutaneous Electrical Acupoint Stimulation Experimental Treatment 1 Intervention

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.

Group II: No Transcutaneous Electrical Acupoint Stimulation Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Jyoti Pandya

Lead Sponsor

Trials

1

Recruited

70+

Findings from Research

Transcutaneous electrical acupoint stimulation (TEAS) significantly reduces the incidence of postoperative nausea and vomiting (PONV) after general anesthesia, with a relative risk of 0.54 based on a meta-analysis of 14 randomized controlled trials involving 1653 participants.

TEAS not only lowers the need for antiemetic rescue medications but also reduces the incidence of dizziness and pruritus, making it a safe and effective option for managing PONV in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical acupoint stimulation for preventing postoperative nausea and vomiting after general anesthesia: A meta-analysis of randomized controlled trials. Chen, J., Tu, Q., Miao, S., et al.[2022]

Aromatherapy (AT) was found to be 100% effective in managing postdischarge nausea and vomiting (PDNV) in ambulatory surgical patients, compared to 67% effectiveness with standard care (SC).

For postoperative nausea and vomiting (PONV), the AT group had a similar incidence (52%) to the SC group (48%), but overall satisfaction with treatment was high in both groups, indicating that AT is a viable option for managing nausea in surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Aromatherapy to Standard Care for Relief of PONV and PDNV in Ambulatory Surgical Patients. Stallings-Welden, LM., Doerner, M., Ketchem, EL., et al.[2019]

Postoperative nausea and vomiting are common and can pose risks for patients after surgery, making effective management important.

Complementary therapies such as acupressure, acupuncture, and aromatherapy may provide relief for patients experiencing these unpleasant symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative therapy applications for postoperative nausea and vomiting. Chiravalle, P., McCaffrey, R.[2019]

The study found that postoperative nausea and vomiting (PONV) remains a common issue among patients undergoing elective gastrointestinal or gynecologic surgeries, with a significant correlation to longer anesthesia times.

Only a small percentage of patients received appropriate evidence-based treatment for PONV, indicating a need for better education and adherence to guidelines among healthcare providers to improve patient outcomes and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of the management and incidence of postoperative nausea and vomiting. Szachnowicz, B., Pawasauskas, J., Brothers, T.[2022]

Aromatherapy using isopropyl alcohol vapour was found to be more effective than a saline placebo in reducing the need for rescue anti-emetics in patients experiencing postoperative nausea and vomiting, based on a review of nine studies with 402 participants.

However, isopropyl alcohol was not as effective as standard anti-emetic treatments, indicating that while it may provide some benefit, it should not replace conventional therapies for managing postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatherapy for treatment of postoperative nausea and vomiting. Hines, S., Steels, E., Chang, A., et al.[2021]

The implementation of a standardized postoperative nausea and vomiting prophylaxis guideline for 817 patients undergoing anterior cruciate ligament reconstruction significantly reduced the emesis rate from 17% to 5%.

The reduction in nausea and vomiting was likely linked to a decrease in opioid use, as the percentage of patients managed without opioids increased from 16% to 38% after the guideline was put in place.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing postoperative nausea and vomiting in pediatric patients undergoing anterior cruciate ligament reconstruction: A quality report. Muhly, WT., Ganley, T., Jantzen, E., et al.[2021]

The updated guidelines on postoperative nausea and vomiting (PONV) provide evidence-based strategies for identifying and managing patients at risk for PONV, based on a comprehensive review of current medical literature.

These guidelines recommend effective antiemetic therapies, including both single and combination treatments, as well as nonpharmacologic approaches, to prevent and treat PONV in both adults and children undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus guidelines for the management of postoperative nausea and vomiting. Gan, TJ., Diemunsch, P., Habib, AS., et al.[2022]

Postoperative nausea and vomiting remain significant issues for patients after surgery, indicating a need for improved management strategies.

Enhancing nursing knowledge and fostering a culture of learning can help address these symptoms and improve patient care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do nurses know about postoperative nausea and vomiting? Lewthwaite, BJ.[2009]

A hot water extract of black tea was shown to effectively reduce diarrhoea in various rodent models, indicating its potential as an antidiarrhoeal treatment.

The antidiarrhoeal effect of the black tea extract is influenced by the opioid system, as evidenced by naloxone's ability to inhibit its activity, suggesting a specific mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiarrhoeal activity of hot water extract of black tea (Camellia sinensis). Besra, SE., Gomes, A., Ganguly, DK., et al.[2015]

In a study involving 45 mice, daily oral administration of green tea catechins showed no significant complications in wound healing after laparotomy, indicating safety in this context.

While the treatment group exhibited lower mean energy required to rupture the wound and increased fibroblast proliferation by postoperative day 21, overall wound healing metrics were similar to the placebo group, suggesting that catechins have a mild effect on wound healing that merits further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative polyphenon E, a green tea extract, does not affect the wound complication rate in mice after sham laparotomy yet has an inhibitory effect on wound healing. Hoffman, A., Baxter, R., Nasar, A., et al.[2018]

The combination of Polyphenon E and Siliphos (PES) significantly inhibited tumor growth in murine models, particularly reducing subcutaneous tumor size and the number and size of liver metastases when administered perioperatively.

Importantly, PES did not impair wound healing, as evidenced by unchanged abdominal wound breaking strength and collagen content, suggesting it could be a safe option for perioperative anticancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative polyphenon E- and siliphos-inhibited colorectal tumor growth and metastases without impairment of gastric or abdominal wound healing in mouse models. Yan, X., Gardner, TR., Grieco, M., et al.[2021]

The hot water extract of black tea significantly accelerates gastrointestinal transit in mice, indicating its potential as a natural gastrokinetic agent.

The prokinetic effects of black tea are likely mediated through cholinergic mechanisms and involve the thearubigin fraction, while nitric oxide and prostaglandins also play a partial role in enhancing gastrointestinal motility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prokinetic effect of black tea on gastrointestinal motility. Chaudhuri, L., Basu, S., Seth, P., et al.[2019]

In a clinical trial involving 99 primiparous women, green tea ointment significantly reduced episiotomy pain and improved wound healing compared to a placebo and routine care, with results showing lower pain levels and better healing scores on days 5 and 10 post-delivery.

The study confirmed the presence of beneficial compounds in green tea, such as phenolic and flavonoid compounds, which may contribute to its analgesic and wound-healing properties, suggesting that green tea ointment could be a safe and effective treatment option for post-episiotomy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Shahrahmani, H., Kariman, N., Jannesari, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical acupoint stimulation for preventing postoperative nausea and vomiting after general anesthesia: A meta-analysis of randomized controlled trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Aromatherapy to Standard Care for Relief of PONV and PDNV in Ambulatory Surgical Patients. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Alternative therapy applications for postoperative nausea and vomiting. [2019]

4. England pubmed.ncbi.nlm.nih.gov

An analysis of the management and incidence of postoperative nausea and vomiting. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Aromatherapy for treatment of postoperative nausea and vomiting. [2021]

6. France pubmed.ncbi.nlm.nih.gov

Reducing postoperative nausea and vomiting in pediatric patients undergoing anterior cruciate ligament reconstruction: A quality report. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Consensus guidelines for the management of postoperative nausea and vomiting. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

What do nurses know about postoperative nausea and vomiting? [2009]

9. England pubmed.ncbi.nlm.nih.gov

Antidiarrhoeal activity of hot water extract of black tea (Camellia sinensis). [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Perioperative polyphenon E, a green tea extract, does not affect the wound complication rate in mice after sham laparotomy yet has an inhibitory effect on wound healing. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Perioperative polyphenon E- and siliphos-inhibited colorectal tumor growth and metastases without impairment of gastric or abdominal wound healing in mouse models. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Prokinetic effect of black tea on gastrointestinal motility. [2019]

13. England pubmed.ncbi.nlm.nih.gov

The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. [2022]