Clinical trial NCT01798316: IV Acetaminophen for Postoperative Analgesia
Official title: IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Nausea
Postoperative Vomiting
Keywords: IV Acetaminophen
Laparoscopic cholecystectomy
Postoperative nausea
Postoperative vomiting
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Postoperative Nausea and Vomiting (PONV).
timeFrame: 4 hours plus/minus 30 minutes
Secondary outcomes:
measure: Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
timeFrame: Up to two days following surgery
measure: Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
timeFrame: 4 hours plus/minus 30 minutes
measure: Patient Satisfaction on a 5 Point Likert Scale
timeFrame: Up to one week following surgery
measure: Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
timeFrame: 1 hour following surgery
Other outcomes:
measure: Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
timeFrame: 1 hour following surgery
measure: Narcotic Use During PACU Stay
timeFrame: 4 hours plus/minus 30 minutes
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Syosset
country: United States
facility: Syosset Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Frank J Overdyk, MD
role: PRINCIPAL_INVESTIGATOR
References: