IV Acetaminophen for Postoperative Analgesia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.

Detailed Description
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The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.

Official Title
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IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain, Postoperative Nausea, Postoperative Vomiting

Intervention / Treatment
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* Drug: IV Acetaminophen
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is undergoing pre-scheduled laparoscopic cholecystectomy; American Society of Anesthesiology patient classification status I-II Exclusion Criteria: Regular preoperative use of or opioids, Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV. Subjects converted to open laparoscopic cholecystectomy Known allergy/hypersensitivity to acetaminophen Use of opioids prior to commencement of the study (<7 days) Patients with chronic pain conditions or disease requiring pain control Abnormal liver function Known or suspected alcohol, drug or opiate abuse or dependence Patients with a BMI of greater than 35 Other physical, mental or medical conditions that could effect participation. Abnormal renal function; serum creatinine>2gm/dl

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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<br>IV Acetaminophen administered on admission to post-anesthesia care unit | Drug: IV Acetaminophen<br>* Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen<br>* Other names: Ofirmev;|
| Active Comparator: Standard of care<br>Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit | Drug: Standard of Care<br>* Standard of care pain management regimen, no IV Acetaminophen,<br>* Other names: As per provider: Opioids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Nausea and Vomiting (PONV). | Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching. | 4 hours plus/minus 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Post Discharge Nausea and Vomiting (PDNV) | Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge. | Up to two days following surgery | 
| Highest Pain Intensity Score Using Numeric Rating Scale (NRS) | Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities. | 4 hours plus/minus 30 minutes | 
| Patient Satisfaction on a 5 Point Likert Scale | Number of patients very satisfied or satisfied with pain and PONV management during hospital stay | Up to one week following surgery | 
| Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale | Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities | 1 hour following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV Acetaminophen, Laparoscopic cholecystectomy, Postoperative nausea, Postoperative vomiting