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

NCT ID: NCT02102555

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-05-03

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.

Conditions

Post Operative Pain; Post Operative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

IV acetaminophen

Intervention Type: DRUG

Single dose of one gram of IV acetaminophen given in pre-operative area

Placebo

Patients in the placebo arm will receive normal saline in the pre-operative area.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo (IV normal saline)

Interventions

IV acetaminophen

Single dose of one gram of IV acetaminophen given in pre-operative area

Intervention Type: DRUG

placebo

placebo (IV normal saline)

Intervention Type: DRUG

Other Intervention Names

Ofirmev; paracetamol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MercyOne Des Moines Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren D Allan, DO

Role: PRINCIPAL_INVESTIGATOR

Mercy Medical Center-Des Moines General Surgery Residency

Locations

Mercy Medical Center-Des Moines

Des Moines, Iowa, United States

Countries

United States

Other Identifiers

MMC2013-25

Identifier Type: -

Identifier Source: org_study_id