Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting (IV)

A Double-blind Randomized, Placebo-controlled Study to Determine the Effectiveness of Pre-operative IV Acetaminophen Administration in Reducing Post-operative Pain, Nausea, and Vomiting in the Outpatient Setting

The purpose of this study is to determine whether a single dose of IV acetaminophen can improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient satisfaction, time to readiness of discharge, and the amount of opiates post operatively will also be measured.

Study Overview

• Status: Terminated
• Conditions: Post Operative Pain; Post Operative Nausea and Vomiting
• Intervention / Treatment: Drug: IV acetaminophen; Drug: placebo

Detailed Description

The purpose of this study is to determine if using a one time pre-operative dose of IV acetaminophen has an effect on post-operative nausea, vomiting, and pain. This is a randomized, double-blind, placebo-controlled prospective study on patients from the Katzmann Breast Center undergoing outpatient breast surgery (including excisional biopsy, lumpectomy, sentinel lymph node biopsy, axillary node dissection, or ductal excision).

IV acetaminophen (paracetamol) has been in Europe and other countries. In the U.S. the FDA approved IV acetaminophen (Ofirmev) in November of 2010. Since then, it has been used in many different ways, but most commonly in the first 24 hours post operative recovery period.

There will be two arms included in this study. Patients in Arm One will receive a one gram dose of IV acetaminophen in the pre-operative area. Patients in Arm Two will receive a dose of the placebo (IV normal saline). The medication will be disguised in the same bag as the normal saline, so no one (including the patient) in the pre-operative area will know which arm the patient is in. This prospective, randomized, double blind study will compare post-operative nausea, vomiting, and pain rates in patients from both arms.

The primary endpoint of this study will be to compare post-operative pain in patients receiving a pre-operative dose of IV acetaminophen to patients receiving the normal saline placebo. Secondary endpoints will include post-operative nausea and vomiting, recovery times, and overall satisfaction of pain management throughout their experience (assessed on post operative day one). If this study shows that IV acetaminophen given in the pre-operative setting decreases post-operative nausea, vomiting, and/or pain and/or shortens recovery time, and improves patient satisfaction in regards to their pain management, it could also become a routine medication given to all patients in the pre-operative setting.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center-Des Moines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Each of the following must be met:

• Greater than or equal to 18 years of age.
• Female
• Undergoing outpatient breast surgery (unilateral or bilateral surgery)

Exclusion Criteria:

If ANY of the following apply:

• History of an allergy or hypersensitivity to acetaminophen (oral, rectal, or IV)
• Chronic alcoholism
• Severe deficiency of liver and/or kidney
• Any patient unable to sign informed consent
• Pregnancy
• Any patient currently enrolled in another experimental protocol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV acetaminophen; Patients in the IV acetaminophen arm will receive a one gram dose of IV acetaminophen in the pre-operative area prior to their surgery.	Drug: IV acetaminophen; Single dose of one gram of IV acetaminophen given in pre-operative area; Other Names: Ofirmev; paracetamol
Placebo Comparator: Placebo; Patients in the placebo arm will receive normal saline in the pre-operative area.	Drug: placebo; placebo (IV normal saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting	first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea and vomiting (PONV)	patient-rated postoperative nausea and vomiting (PONV) on visual analog scale	first postoperative day
time until readiness of discharge	time until readiness of discharge: measured from arrival to the recover room to discharge-order-written time (DOW time)	first postoperative day
IV analgesic consumption in recovery room	intravenous analgesic consumption in recovery room: converted to morphine-equivalents	first postoperative day

Collaborators and Investigators

• Sponsor: MercyOne Des Moines Medical Center
• Investigators: Principal Investigator: Lauren D Allan, DO, Mercy Medical Center-Des Moines General Surgery Residency

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): May 3, 2017

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; 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: MMC2013-25