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

Phase 3

Terminated

• Conditions: Post Operative Nausea and Vomiting; Post Operative Pain
• Interventions: Drug: placebo; Drug: IV acetaminophen

• Registration Number: NCT02102555
• Lead Sponsor: MercyOne Des Moines Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Primary Completion: 2017-05-03
• Study Completion: 2017-05-03
• Status Verified: 2019-08
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients in the placebo arm will receive normal saline in the pre-operative area.
IV acetaminophen	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mercy Medical Center-Des Moines; 🇺🇸 Des Moines, Iowa, United States