Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT05975385 | Completed FDA Device

• 1 other identifier: H-53767
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis, Acute; Cholelithiasis; Nausea, Postoperative; Vomiting, Postoperative; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain

  24 hours

• Total opioids used

  24 hours

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Control

NO INTERVENTION

No acupuncture treatment provided

Interventions

Acupuncture DEVICE

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

Acupuncture

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

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

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: October 9, 2023
• Primary Completion: January 16, 2026
• Study Completion: February 10, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)