Acupuncture for Postoperative Nausea and Vomiting

Overseen By Jaime Ortiz, MD, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must be taking: Ondansetron, Dexamethasone

Disqualifiers: Open cholecystectomy, Renal dysfunction, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of acupuncture as a treatment for postoperative nausea and vomiting?

Research shows that acupuncture, including electrical acupoint stimulation, can help reduce nausea and vomiting after surgery. Studies have found it to be effective in comparison to some medications and generally safe for patients. ^{1 2 3 4 5}

Is acupuncture safe for treating postoperative nausea and vomiting?

Research shows that acupuncture, including electroacupuncture, is generally safe for treating postoperative nausea and vomiting. Some minor side effects like pain and itching at the acupuncture site have been reported, but they are temporary and resolve quickly. ^{2 3 6 7 8}

How does acupuncture differ from other treatments for postoperative nausea and vomiting?

Acupuncture is unique because it is a non-drug treatment that involves stimulating specific points on the body, such as the pericardium point 6 (PC6), to prevent nausea and vomiting after surgery. Unlike traditional drug therapies, acupuncture is considered safe and effective without the side effects associated with medications. ^{1 2 6 9 10}

Eligibility Criteria

This trial is for patients aged 18-64 who are scheduled for laparoscopic gallbladder removal at Ben Taub Hospital and have a moderate risk of complications from surgery. It's not for those with communication barriers, mental health issues, planned open surgery, kidney problems or allergies to anesthesia.

Inclusion Criteria

I am scheduled for a gallbladder removal surgery at Ben Taub Hospital.

My overall health is good to moderately impaired.

I am between 18 and 64 years old.

Exclusion Criteria

I can communicate clearly without any major issues.

I or my surgeon have decided against a specific treatment.

My kidney function is normal, with a creatinine level at or below 1.2.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point during laparoscopic cholecystectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for incidence of postoperative nausea and vomiting and other outcomes

24 hours

Postoperative monitoring at 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

Treatment Details

Interventions

• Acupuncture

Trial Overview The study tests if acupuncture on specific points during surgery can reduce nausea and vomiting after the operation. This is in addition to standard drugs given for these symptoms. Patients will be compared to see if acupuncture offers extra benefits over medication alone.

Participant Groups

Group I: Acupuncture Experimental Treatment 1 Intervention

Group Acupuncture: Points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang will be needled using Seirin L Type 0.25 X 40 mm needles. MH 6 is located 2 cun (a traditional Chinese unit of length) above the wrist crease in between the tendons of palmaris longus and flexor carpi radialis. LI 4 is in the middle of first and second metacarpal bones. Yin Tang is located between the eyebrows. All needles will be removed once skin closure begins, and before emergence and extubation.

Group II: Control Active Control 1 Intervention

No acupuncture treatment provided

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Findings from Research

In a study involving 450 parturients undergoing elective cesarean delivery, both electrical acustimulation and ondansetron significantly reduced the occurrence of postoperative nausea and vomiting (PONV) during and for 6 hours after surgery.

Patient satisfaction regarding PONV control was higher in the groups receiving either electrical acustimulation or ondansetron compared to the placebo group, indicating that both treatments are effective alternatives for managing PONV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acupuncture on nausea and/or vomiting during and after cesarean section in comparison with ondansetron. El-Deeb, AM., Ahmady, MS.[2022]

Electrical acupoint stimulation significantly reduces the incidence of postoperative nausea and vomiting, with a risk ratio of 0.49 based on a meta-analysis of 26 studies involving 2064 patients.

This method also decreases the need for antiemetic rescue medications, showing effectiveness whether applied before, during, or after surgery, and it has a low incidence of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of electrical acupoint stimulation for postoperative nausea and vomiting: A systematic review and meta-analysis. Lu, L., Xie, C., Li, X., et al.[2023]

Acupuncture treatment prior to surgery has been shown to significantly reduce the incidence of postoperative nausea (PON) compared to standard antiemetic prophylaxis, although it did not have a similar effect on vomiting.

The review of 21 studies suggests that acupuncture, both invasive and non-invasive, is a promising non-pharmacologic option for minimizing postoperative nausea with minimal side effects, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture prior to surgery to minimise postoperative nausea and vomiting: a systematic review. Holmér Pettersson, P., Wengström, Y.[2018]

Acupuncture has been shown to be effective in preventing and treating postoperative nausea and vomiting, supported by modern clinical research over the past 20 years.

Future studies should explore how different anesthetics, operation durations, and types of surgery may influence acupuncture's effectiveness, as well as how to enhance its therapeutic effects through proper syndrome differentiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current overseas researches on prevention and treatment of postoperative nausea and vomiting with acupuncture]. Ma, TT., Wu, X., Liang, FR.[2010]

Transcutaneous electrical acupoint stimulation (TEAS) at the P6 acupoint significantly reduced the incidence of postoperative nausea (18% vs. 37%) and vomiting (12.5% vs. 32.5%) in patients undergoing supratentorial craniotomy, based on a study of 80 patients.

TEAS serves as an effective complementary treatment to standard antiemetic medications, enhancing the prevention of nausea and vomiting after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupoint stimulation for postoperative nausea and vomiting in patients undergoing supratentorial craniotomy. Wang, XQ., Yu, JL., Du, ZY., et al.[2013]

A survey of 161 patients at a Western teaching hospital revealed that 65% would consider acupuncture for managing postoperative nausea and vomiting (PONV), indicating a strong interest in this treatment option.

Despite only 15.5% of participants initially knowing that acupuncture could help with nausea and vomiting, 87% expressed willingness to try it after learning about its potential benefits, suggesting a need for better education on alternative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of and willingness to try acupuncture for postoperative nausea and vomiting: an Australian survey of surgical patients. Weeks, EM., Trinca, J., Zheng, Z.[2018]

Electroacupuncture significantly reduces the incidence of postoperative nausea (PON) and vomiting (POV) within 6 hours after surgery, as shown in a meta-analysis of 8 randomized controlled trials involving 899 participants.

While electroacupuncture did not show a significant difference in overall postoperative nausea and vomiting (PONV) rates compared to control groups, it effectively decreased the need for antiemetic medications, indicating its potential as a supportive treatment in managing PONV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suggested Electroacupuncture for Postoperative Nausea and Vomiting: A Comprehensive Meta-Analysis and Systematic Review of Randomized Controlled Trials. Han, Z., Zhang, X., Yang, H., et al.[2023]

Acupuncture after total knee arthroplasty (TKA) may help reduce the incidence of postoperative nausea and vomiting (PONV), suggesting a potential benefit for patients recovering from surgery.

While acupuncture did not show immediate effects on pain levels (measured by VAS scores) within the first 48 hours post-surgery, it did lead to reduced pain scores after 48 hours, indicating a delayed analgesic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Acupuncture in Postoperative Pain Management of Patients Undergoing Knee Arthroplasty Surgery: A Systematic Review and Meta-Analysis. Lindsey, MH., Mortensen, S., Xu, H., et al.[2023]

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]

Acupuncture at the PC6 point significantly reduced the incidence of postoperative nausea in women undergoing elective open hysterectomy, with nausea rates dropping from 29.2% in the control group to 6.1% in the acupuncture group.

The acupuncture treatment also decreased the need for rescue medication (metoclopramide) from 33.3% in the control group to 10.2% in the acupuncture group, indicating its efficacy in managing nausea post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Acupuncture on Prevention of Nausea and Vomiting and Plasma Serotonin Values in the Hysterectomy Postoperative Period: a Randomized Clinical Trial. Pires, MC., Barros, GAM., Fonseca, LGF., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Effect of acupuncture on nausea and/or vomiting during and after cesarean section in comparison with ondansetron. [2022]

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

Efficacy and safety of electrical acupoint stimulation for postoperative nausea and vomiting: A systematic review and meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Acupuncture prior to surgery to minimise postoperative nausea and vomiting: a systematic review. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Current overseas researches on prevention and treatment of postoperative nausea and vomiting with acupuncture]. [2010]

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

Electroacupoint stimulation for postoperative nausea and vomiting in patients undergoing supratentorial craniotomy. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Knowledge of and willingness to try acupuncture for postoperative nausea and vomiting: an Australian survey of surgical patients. [2018]

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

Suggested Electroacupuncture for Postoperative Nausea and Vomiting: A Comprehensive Meta-Analysis and Systematic Review of Randomized Controlled Trials. [2023]

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

The Role of Acupuncture in Postoperative Pain Management of Patients Undergoing Knee Arthroplasty Surgery: A Systematic Review and Meta-Analysis. [2023]

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

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

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Acupuncture on Prevention of Nausea and Vomiting and Plasma Serotonin Values in the Hysterectomy Postoperative Period: a Randomized Clinical Trial. [2022]