IV Acetaminophen for Postoperative Analgesia

IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Postoperative Nausea; Postoperative Vomiting
• Intervention / Treatment: Drug: IV Acetaminophen; Drug: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • Syosset, New York, United States, 11791
      • Syosset Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV Acetaminophen; IV Acetaminophen administered on admission to post-anesthesia care unit	Drug: IV Acetaminophen; Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen; Other Names: Ofirmev
Active Comparator: Standard of care; Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit	Drug: Standard of Care; Standard of care pain management regimen, no IV Acetaminophen,; Other Names: As per provider: Opioids

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Requiring Rescue Analgesia for Breakthrough Pain	Number of patients requiring rescue analgesia medication during first hour of PACU stay	1 hour following surgery
Narcotic Use During PACU Stay	Narcotic medication administered during PACU stay in morphine milligram equivalents	4 hours plus/minus 30 minutes

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Frank J Overdyk, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; IV Acetaminophen; Postoperative vomiting; Postoperative nausea
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 12-0409; IRB #12-409B (Other Identifier: North Shore-Long Island Jewish Health System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO