Back to resultsIV Acetaminophen for Postoperative Analgesia
Primary Purpose
Postoperative Pain, Postoperative Nausea, Postoperative Vomiting
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring IV Acetaminophen, Laparoscopic cholecystectomy, Postoperative nausea, Postoperative vomiting
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
Sites / Locations
- North Shore University Hospital
- Long Island Jewish Medical Center
- Syosset Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IV Acetaminophen
Standard of care
Arm Description
IV Acetaminophen administered on admission to post-anesthesia care unit
Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Patient Satisfaction on a 5 Point Likert Scale
Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01798316
Brief Title
IV Acetaminophen for Postoperative Analgesia
Official Title
IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator left the institution
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea, Postoperative Vomiting
Keywords
IV Acetaminophen, Laparoscopic cholecystectomy, Postoperative nausea, Postoperative vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV Acetaminophen
Arm Type
Active Comparator
Arm Description
IV Acetaminophen administered on admission to post-anesthesia care unit
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Description
Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
As per provider: Opioids
Intervention Description
Standard of care pain management regimen, no IV Acetaminophen,
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Nausea and Vomiting (PONV).
Description
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.
Time Frame
4 hours plus/minus 30 minutes
Secondary Outcome Measure Information:
Title
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
Description
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.
Time Frame
Up to two days following surgery
Title
Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
Description
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.
Time Frame
4 hours plus/minus 30 minutes
Title
Patient Satisfaction on a 5 Point Likert Scale
Description
Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
Time Frame
Up to one week following surgery
Title
Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
Description
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
Time Frame
1 hour following surgery
Other Pre-specified Outcome Measures:
Title
Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
Description
Number of patients requiring rescue analgesia medication during first hour of PACU stay
Time Frame
1 hour following surgery
Title
Narcotic Use During PACU Stay
Description
Narcotic medication administered during PACU stay in morphine milligram equivalents
Time Frame
4 hours plus/minus 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank J Overdyk, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Syosset Hospital
City
Syosset
State/Province
New York
ZIP/Postal Code
11791
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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IV Acetaminophen for Postoperative Analgesia
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