Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Baylor College of Medicine

Status: Enrolling

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

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05975385

H-53767

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Acupuncture

Experimental group

Description:

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.

Treatment:

Device: Acupuncture

Control

No Intervention group

Description:

No acupuncture treatment provided