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Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery

NCT01852955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-03-14

Study results available
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Summary

Recent evidence demonstrates that perioperative pain continues to be poorly managed among ambulatory surgical patients. More importantly, few interventions that minimize postoperative pain have also shown to improve patient overall quality of post-surgical recovery. Ketorolac has been used to minimize perioperative pain despite the lack of evidence for its use when administered as a single dose preventive strategy.Ketorolac has also been associated with a higher incidence of perioperative hematomas and the need for surgical re-exploration after breast surgery.

Systemic acetaminophen has become recently available in The United States. In contrast to ketorolac, systemic acetaminophen has not been reported to have adverse side effects on patients undergoing breast surgery. Although evidence suggests that a single dose perioperative acetaminophen reduces postoperative pain, it remains unknown if a single dose intravenous acetaminophen improves postoperative quality of recovery after ambulatory surgery.

The main objective of the current investigation is to evaluate the effect of a single dose systemic acetaminophen on postoperative quality of recovery after ambulatory breast surgery. We also seek to determine if systemic acetaminophen would decrease postoperative pain and the time to hospital discharge in the same population.

Significance: The current project evaluates a potential intervention to improve perioperative pain and recovery after ambulatory breast surgery. Postoperative pain in the ambulatory surgical patients has been shown consistently to be poorly managed.

Conditions

Interventions

DRUG

IV acetaminophen

Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure

DRUG

Placebo

Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen

Sponsors & Collaborators

Principal Investigators

  • Gildasio De Oliveira, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852955 on ClinicalTrials.gov