Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT ID: NCT05975385

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

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

Control

No acupuncture treatment provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jaime Ortiz

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ben Taub Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jaime Ortiz, MD, MBA

Role: CONTACT

jaimeo@bcm.edu

713-873-2860

Facility Contacts

Jaime Ortiz, MD,MBA

Role: primary

Other Identifiers

H-53767

Identifier Type: -

Identifier Source: org_study_id