- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05975385
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
March 1, 2026 updated by: Jaime Ortiz, Baylor College of Medicine
Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Ben Taub Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient ages 18-64
- American Society of Anesthesiology Physical Status I, II or III
- Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital
Exclusion Criteria:
- Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
- Allergy to any of the standard anesthetic agents
- Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
- Patient or surgeon refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupuncture
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.
|
Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang
|
|
No Intervention: Control
No acupuncture treatment provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative nausea and vomiting
Time Frame: Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
|
Incidence of nausea and vomiting after surgery
|
Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain
Time Frame: 24 hours
|
Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery
|
24 hours
|
|
Total opioids used
Time Frame: 24 hours
|
Total opioid given, converted to oral morphine equivalents
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2023
Primary Completion (Actual)
January 16, 2026
Study Completion (Actual)
February 10, 2026
Study Registration Dates
First Submitted
July 26, 2023
First Submitted That Met QC Criteria
August 2, 2023
First Posted (Actual)
August 3, 2023
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
March 1, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Signs and Symptoms, Digestive
- Digestive System Diseases
- Biliary Tract Diseases
- Gallbladder Diseases
- Vomiting
- Nausea
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Cholecystitis
- Pain, Postoperative
- Postoperative Nausea and Vomiting
- Cholecystitis, Acute
- Cholelithiasis
- Therapeutics
- Complementary Therapies
- Acupuncture Therapy
Other Study ID Numbers
- H-53767
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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