Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery
Condition: Pain
Study type: Interventional

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.
    

Detailed description: 
      Patients will be recruited up to the day of surgery. They will be then randomized using a
      computer generated table of random numbers to two groups: Group A (IV acetaminophen 1000 mg
      over 15 minutes at the start of surgical closure) and Group B (placebo group-same volume of
      saline solution administered in the same fashion).This dose has been commonly used in other
      studies involving IV acetaminophen.6 Both drugs will be identical and will be prepared by
      hospital pharmacy. After placement of standard ASA monitors, induction will be performed with
      0.1mcg/kg/min of remifentanil IV, propofol 1.5-2.5 mg/kg IV and succinylcholine 1-2 mg/kg IV.
      Tracheal intubation will be performed using a MAC 3 blade and a size 7 endotracheal tube.
      Maintenance will be achieved with remifentanil infusion titrated to keep the blood pressure
      within 20% of baseline values and sevoflurane titrated to keep a bispectral index monitor
      between 40 and 60. Patients will receive ondansetron 4mg IV and dexamethasone 4 mg IV for
      postoperative nausea and vomiting prophylaxis. In the recovery room patients will receive
      hydromorphone IV in divided doses to keep pain <4/10(scale where 0 means no pain and 10 is
      the worst pain) and metoclopramide 10 mg IV as rescue antiemetic. Data will be collected by a
      research assistant blinded to the group allocation. Data collected will involve pain at PACU
      arrival (NRS-0-10), presence of nausea and vomiting, severity of nausea and vomiting, total
      opioid consumption in PACU, time to discharge using a Modified Postanaesthetic Discharge
      Scoring System (MPADSS) 9, total opioid consumption 24 hours, QoR40 24hours after surgery.8
    

Intervention name(s): IV acetaminophen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure; Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Outpatient; Surgery; Breast; Pain