Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Not Applicable

Recruiting

• Conditions: Cholelithiasis; Vomiting, Postoperative; Nausea, Postoperative; Cholecystitis, Acute; Pain, Postoperative
• Interventions: Device: Acupuncture

• Registration Number: NCT05975385
• Lead Sponsor: Baylor College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-03
• Study Start: 2023-10-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting	Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours	Incidence of nausea and vomiting after surgery

Secondary Outcome Measures

Name	Time	Method
Total opioids used	24 hours	Total opioid given, converted to oral morphine equivalents
Postoperative pain	24 hours	Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery

Trial Locations

Locations (1)

Ben Taub Hospital; 🇺🇸 Houston, Texas, United States