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N/A N=70 Randomized Double-blind Prevention

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

Pain

Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Quality of Recovery at 24 Hours(QoR-40 Instrument) — 189; 183 units on a scale — p=.01

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
IV acetaminophen (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Northwestern University
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Recovery at 24 Hours(QoR-40 Instrument)
189; 183 .01 sig
SECONDARY
Postoperative Opioid Consumption
20; 30 .04 sig
SECONDARY
Postoperative Pain in the Post Anesthesia Care Unit
255; 240 .36

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.

Eligibility Criteria

Inclusion Criteria

  • Outpatient lumpectomy
  • ASA I and II
  • Age between 18-70

Exclusion:

  • Pregnancy
  • History of liver disease
  • Unable to understand the informed consent
  • Chronic pain with use of opioid in the last week
  • Allergy to acetaminophen

Drop-out: surgeon or patient request

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01852955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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