Efficacy of IV Acetaminophen for Pain Management
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Placebo; IV acetaminophen
Intervention description: 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.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 68.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: IV Acetaminophen; Ofirmev; Post-operative pain

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.
    

Eligibility criteria:

        Inclusion Criteria:

        -Female patients undergoing major gynecologic surgery via an open abdominal approach. The
        included surgeries would be exploratory laparotomy with or without removal of uterus,
        fallopian tubes, or ovaries.

        Exclusion Criteria:

          -  Patients with baseline preoperative liver function enzymes (AST and ALT) that are
             greater than twice the upper limit of normal would be excluded.

          -  Patients with baseline CrCl <30.

          -  Patients that require intensive postoperative care and delayed extubation will
             typically require additional sedation which would impede adequate evaluation of the
             two study pain regimens as they are designed to be patient controlled.

          -  Patients with complications unrelated to the pain regimens that prolong their stay
             would be excluded from the evaluation of hospital stay and cost effectiveness
             analyses. Examples would include but are not limited to pre-renal azotemia and acute
             renal failure; pneumonia; venous thromboembolism; or need for re-exploration
             laparotomy.

          -  Allergy to acetaminophen would exclude those patients set to enter the experimental IV
             acetaminophen study arm. One exception would be if the allergy were trivial and
             related to route of administration such as mild nausea with oral acetaminophen.

          -  Patients that undergo a bowel resection during surgery as it may adversely effect
             return of bowel function

          -  Patients that have required regular opioid intake for the 7 days preceding surgery.

          -  NSAIDs within 8 hours of surgery.

          -  Chronic steroid use with the exception of low-dose inhaled steroid formulations.

          -  Chronic alcohol or drug abuse.

          -  Patients currently pregnant.

          -  Patients unable to provide informed consent.

          -  Age >85

          -  Any physical, medical, and mental condition that would make participation in the study
             inadvisable.