Efficacy of IV Acetaminophen for Pain Management
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators' goal in this planned prospective, randomized, patient blinded study is to
      compare our standard of care as the control group to an experimental group in which patients
      receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8
      doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will
      include amount of rescue opioids required, time to return of bowel function, length of
      hospital stay, and patient satisfaction. The hypothesis is that the addition of IV
      acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of
      associated gastrointestinal side effects including nausea, vomiting, bloating, and
      constipation. The hope is that it will affect the final outcome of quicker return of bowel
      function, increased patient satisfaction, shortened hospital stay and prove to be an overall
      more effective postoperative pain management approach.
    

Detailed description: 
      This is a patient-blinded prospective study in which patients that undergo major gynecologic
      surgery via an open abdominal approach will be randomized into two arms:

        1. Control Group: Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours
           post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses
           prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then
           patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder
           of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours
           for a total of eight doses with the first dose being given at time of anesthesia
           induction.

        2. Experimental Group: Morphine PCA for the initial 24 hours post-operation with low-dose
           basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg
           will be given every six hours for a total of eight doses with the first dose being given
           at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be
           used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen
           for the remainder of their hospital stay.

      Outcomes that will be analyzed include the amount of opioids used; time to return of bowel
      function designated as passage of flatus; time to first bowel movement if it occurs while
      inpatient; duration of hospital stay; and patient symptoms and satisfaction at the 24 and 48
      hour marks as well as at time of discharge.
    

Intervention name(s): Placebo; IV acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.; IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Other intervention name(s): IV Placebo; Ofirmev
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: IV Acetaminophen; Ofirmev; Post-operative pain