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Acupuncture for Postoperative Nausea and Vomiting

N/A

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiology Physical Status I, II or III

Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital

Must not have

Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)

Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if acupuncture reduces nausea/vomiting after laparoscopic surgery when combined with drugs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Acupuncture may cause minor side effects like slight bleeding or bruising where needles are inserted, dizziness, or rare allergic reactions. The procedure is generally considered safe when performed by trained professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My overall health is good to moderately impaired.

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

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can communicate clearly without any major issues.

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

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I am not scheduled for an open gallbladder removal due to concerns about pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of postoperative nausea and vomiting

Secondary study objectives

Postoperative pain

Total opioids used

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AcupunctureExperimental Treatment1 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: ControlActive Control1 Intervention

No acupuncture treatment provided

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture

2011

Completed Phase 3

~1240

0 / 6Eligibility criteria met