Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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<br>* Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang<br>|
| No Intervention: Control<br>No acupuncture treatment provided | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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