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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if acupuncture can reduce nausea and vomiting after gallbladder surgery. It evaluates the effect of adding acupuncture to the standard medications used to prevent these symptoms. Participants will receive either acupuncture during surgery or no acupuncture to compare outcomes. This trial suits individuals planning laparoscopic gallbladder removal at Ben Taub Hospital who do not have specific health conditions, such as kidney issues or allergies to anesthetic agents. As an unphased trial, it provides a unique opportunity to explore alternative methods for enhancing post-surgery recovery.

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 prior data suggests that this acupuncture technique is safe for reducing postoperative nausea and vomiting?

Research shows that acupuncture, especially at the PC6 point on the wrist, is generally safe for treating nausea and vomiting after surgery. Studies have found that patients usually experience few side effects, and when they occur, they are typically mild. For instance, some people might feel slight discomfort where the needle is placed, but this is uncommon.

A review of several studies on electrical acupoint stimulation (a type of acupuncture) found it to be safe, with no serious side effects reported. This suggests that acupuncture can be a safe choice for patients wanting to reduce nausea and vomiting after surgery.

Overall, acupuncture is considered safe for many people, with minimal risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using acupuncture for postoperative nausea and vomiting because it offers a drug-free alternative to traditional medications like antiemetics, which can have side effects. Unlike other treatments that work by blocking certain brain signals or receptors, acupuncture stimulates specific points on the body to promote natural healing processes. This method could provide a more holistic and gentle approach to managing nausea and vomiting, with the potential of fewer side effects and interactions with other medications.

What evidence suggests that acupuncture is effective for reducing postoperative nausea and vomiting?

This trial will compare acupuncture with no intervention for managing postoperative nausea and vomiting. Research has shown that acupuncture can help reduce nausea and vomiting after surgery. A review of several studies found that acupuncture at a specific wrist point, called the PC6 point, significantly reduced early vomiting after surgery. Another study found that techniques like electroacupuncture also helped with these symptoms. Evidence suggests that acupuncture is becoming a popular method for managing nausea and vomiting after surgery. Overall, acupuncture appears to be a promising option for reducing these symptoms. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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pubmed.ncbi.nlm.nih.gov

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Based on current evidence, electroacupuncture significantly reduces the occurrence rate of PON and POV at 6 h after surgery and the use of antiemetic ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0965229923000742

Research trends of acupuncture therapy on postoperative ...

The utilization of acupuncture as a therapeutic intervention for the management of postoperative nausea and vomiting has experienced a notable increase in ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11745642/

Comparative effectiveness of acupoint stimulation for ...

Both TEAS and electroacupuncture, with or without antiemetic, could significantly reduce the incidences of postoperative nausea and/or vomiting after general ...

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journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0082474

A Systematic Review and Meta-Analysis | PLOS One

Meta-analysis showed that PC6 acupuncture significantly reduced the number of cases of early vomiting (postoperative 0-6h) (RR=0.36, 95%CI 0.19,0.71; P=0.003) ...

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journals.lww.com

journals.lww.com/md-journal/fulltext/2020/07310/a_comparison_of_noninvasive_and_invasive.140.aspx

A comparison of noninvasive and invasive acupuncture in...

The effectiveness will be recorded and primary endpoints are the incidences of postoperative nausea (PON), postoperative vomiting (POV), PONVs, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10231798/

Efficacy and safety of electrical acupoint stimulation for ...

The goal of our meta-analysis is to systematically evaluate the efficacy and safety of electrical acupoint stimulation for postoperative nausea and vomiting.

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pubmed.ncbi.nlm.nih.gov

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Stimulation of the wrist acupuncture point PC6 for ...

Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting: a network meta-analysis. Cochrane Database ...

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journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0285943

Efficacy and safety of electrical acupoint stimulation for ...

Electrical acupoint stimulation probably reduce the incidence of postoperative nausea and vomiting, postoperative nausea, postoperative vomiting, and reduce ...

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journals.lww.com/md-journal/fulltext/2020/05290/acupuncture_pc6_for_postoperative_nausea_and.97.aspx

Acupuncture PC6 for postoperative nausea and vomiting at...

This study will provide high-quality current evidence of the effectiveness and optimal time of acupuncture PC6 point for the patient with PONV.