Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Pain, Postoperative Clinical Trial

Official title:

Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975385
• Other study ID #: H-53767
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Baylor College of Medicine
• Contact: Jaime Ortiz, MD, MBA
• Phone: 713-873-2860
• Email: jaimeo[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Cholelithiasis
• Nausea
• Nausea, Postoperative
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting
• Vomiting, Postoperative

Intervention

Device:
• Acupuncture
Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang

Locations

Country	Name	City	State
United States	Ben Taub Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting	Incidence of nausea and vomiting after surgery	Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
Secondary	Postoperative pain	Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery	24 hours
Secondary	Total opioids used	Total opioid given, converted to oral morphine equivalents	24 hours