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Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT05975385
Recruitment Status : Recruiting
First Posted : August 3, 2023
Last Update Posted : October 11, 2023
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cholecystitis, Acute Cholelithiasis Nausea, Postoperative Vomiting, Postoperative Pain, Postoperative Device: Acupuncture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patient will be under general anesthesia when treatment provided. They will not know whether or not they received acupuncture treatment. Postoperative assessors will not know which group the patient is in.
Primary Purpose: Treatment
Official Title: Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial
Actual Study Start Date : October 9, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Device: Acupuncture
Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang
No Intervention: Control
No acupuncture treatment provided


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Total opioids used [ Time Frame: 24 hours ]
    Total opioid given, converted to oral morphine equivalents


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient ages 18-64
  2. American Society of Anesthesiology Physical Status I, II or III
  3. Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital

Exclusion Criteria:

  1. Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures
  2. Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
  3. Allergy to any of the standard anesthetic agents
  4. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
  5. Patient or surgeon refusal
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975385


Contacts
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Contact: Jaime Ortiz, MD, MBA 713-873-2860 jaimeo@bcm.edu

Locations
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United States, Texas
Ben Taub Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jaime Ortiz, MD,MBA         
Principal Investigator: Jaime Ortiz         
Sponsors and Collaborators
Baylor College of Medicine
More Information
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Responsible Party: Jaime Ortiz, Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05975385    
Other Study ID Numbers: H-53767
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: October 11, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cholecystitis
Cholelithiasis
Cholecystitis, Acute
Nausea
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
 Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases