Cholecystitis, Acute, Cholelithiasis, Nausea, Postoperative, Pain, Postoperative, Vomiting, Postoperative
Conditions
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.
Interventions
DEVICEAcupuncture
Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24 hours | Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery |
| Total opioids used | 24 hours | Total opioid given, converted to oral morphine equivalents |
Countries
United States
Outcome results
None listed