Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA

Study Overview
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Brief Summary
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The objective of this study is to determine if IV acetaminophen administered intraoperatively can decrease the dose of narcotics required for adequate pain control and shorten recovery time in the PACU specifically in obese patients at risk for obstructive sleep apnea.

Detailed Description
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Obese adult patients at risk for having OSA will be randomized into two groups: those receiving intraoperative IV acetaminophen and those not receiving the drug. The patients will be blinded to the administration of acetaminophen. For the group randomized to receive the study drug, anesthesia providers will be instructed to administer 1000mg of IV acetaminophen intraoperatively immediately after induction. They may utilize narcotics and other pain medication perioperatively at their discretion according to their perceived patients' needs. Post-operatively in the recovery unit, all patients will be monitored according to current standards with appropriate oxygen supplementation as needed, and they may receive narcotics or other adjuncts as ordered by the anesthesia provider. Recovery nurses will record vital signs, Aldrete score, pain score, and drugs administered per standard protocol. The recovery nurses will be blinded to the study group, and no patients regardless of control vs. study group will be allowed to receive acetaminophen in the PACU or for six hours from surgery end time due to FDA approved dosing of IV acetaminophen no more frequently than every six hours. The patients' recovery data will then be de-identified and reviewed, and each of the groups' recovery time, narcotic use, pain score, and any complications will be examined and compared.

Official Title
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Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy

Conditions
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Cholecystitis, Cholelithiasis, Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: acetaminophen, IV preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity (BMI greater than or equal to 30) Symptoms of obstructive sleep apnea as determined by an OSA questionnaire patients will complete preoperatively Prior diagnosis of obstructive sleep apnea Undergoing laparoscopic cholecystectomy 18 years old or greater Exclusion Criteria: Negative OSA questionnaire or recent negative workup Open cholecystectomy or conversion to open procedure intraoperatively Allergy to acetaminophen Severe hepatic dysfunction Pediatric patients Patients unable to consent for themselves

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV acetaminophen, OSA, laparoscopic cholecystectomy<br>IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy | Drug: acetaminophen, IV preparation<br> <br> * Other names: Ofirmev;|
| No Intervention: OSA, laparoscopic cholecystectomy, narcotics<br>No IV acetaminophen in obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy; patients will receive other modalities for pain control primarily including IV narcotics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in pain scores in PACU | The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in pain scores in the PACU | PACU stay (1-2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced narcotic use in PACU | The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in narcotic use in the PACU and therefore have less adverse events related to increased narcotic use such as respiratory depression or failure requiring prolonged supplemental oxygen or respiratory support, increased nausea and vomiting, longer PACU stay, and allergic reactions. | PACU stay (1-2 hours) | 
| amount of time for recovery in PACU based on Aldrete score | The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in recovery time, i.e., reduction in time to the patient's baseline Aldrete score. | PACU stay (1-2 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystitis, cholelithiasis, obstructive sleep apnea, acetaminophen