A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures

Study Overview
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Brief Summary
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This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.

Detailed Description
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Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room. Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room. Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics. Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures

Conditions
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Postoperative Pain, Intraoperative and Postoperative Opioid Requirements

Intervention / Treatment
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* Drug: Intravenous acetaminophen
* Drug: Intravenous placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing ambulatory surgery under general anesthesia Expected postoperative pain to be mild-moderate Age 18 years or older Have an ASA physical status or 1, 2, or 3 Exclusion Criteria: Anticipated peripheral or neuraxial nerve block Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery Current chronic opioid or tramadol use History of alcohol or opioid abuse Known allergy to the study medications Pregnancy Any health condition requiring greater than 100 micrograms of fentanyl during anesthesia induction Treated with any acetaminophen-containing medication in the previous 8 hours Treated with MAO inhibitors within 10 days prior to surgery Inability to communicate with the investigators and hospital staff Known or impaired liver function

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV Acetaminophen<br>Intraoperative IV acetaminophen administered | Drug: Intravenous acetaminophen<br>* Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.<br>|
| Placebo Comparator: IV Placebo<br>Intraoperative IV normal saline administered | Drug: Intravenous placebo<br>* Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge. |  | Day of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient. |  | Day of Surgery | 
| A secondary outcome for this investigation will be the total dose of morphine administered to the patient. |  | Day of Surgery | 
| A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient. |  | Day of Surgery | 
| A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient. |  | Day of Surgery | 
| A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration. |  | Day of Surgery | 
| A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient. |  | Day of Surgery | 
| Patients will be asked at time of PACU discharge, Overall, how would you rate the study treatments? Responses will be on 0 to 3 scale where 0=poor and 3=excellent. |  | Day of Surgery | 
| Patients will be asked at time of PACU discharge, Overall, how would you rate the level of pain relief from study medication? Responses will be on 0 to 3 scale where 0=poor and 3=excellent. |  | Day of Surgery | 
| Adverse events |  | Up to one year postoperative |