IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to quantify the change in post-operative pain scores and
      narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to
      placebo in women undergoing laparoscopic hysterectomy.
    

Detailed description: 
      Gynecologic surgery has been revolutionized by the incorporation of minimally invasive
      techniques. Procedures that once resulted in multiple day hospital admissions are now being
      performed in outpatient surgery centers. Common factors that contribute to delayed discharge
      are inadequate postoperative pain control and increased nausea and vomiting. A multi-modal
      pain management approach is considered optimal at controlling postsurgical pain, which
      includes combining different analgesics that act in varying mechanisms. By using medications
      that act synergistically, the overall analgesia requirement can oftentimes be decreased.

      Opioids have been found to be highly effective in controlling postoperative pain; however,
      are associated with dose-dependent risks including nausea, vomiting, constipation, urinary
      retention, sedation, and respiratory depression. Subsequently, non-opioid options are
      frequently desired in an attempt to minimize narcotic intake. In the United States,
      intravenous acetaminophen was approved by the US Food and Drug Administration (FDA) in
      November 2010 for the management of mild to moderate pain and the reduction of fever. Since
      this time, multiple studies have analyzed the role of intravenous acetaminophen in both acute
      and postoperative pain; however, none have been specific to laparoscopic hysterectomy. The
      primary study published evaluating intravenous acetaminophen in laparoscopic hysterectomies
      also included multiple other laparoscopic procedures from a variety of specialties including
      general surgery, urology, and urogynecology. In addition, the intravenous acetaminophen was
      started on average 19 hours after the conclusion of the case once the patient controlled
      analgesic was discontinued.

      Improved postsurgical pain control achieved with intravenous acetaminophen may potentially
      lead to same day discharge after major laparoscopic gynecologic procedures. Same day
      discharge after laparoscopic hysterectomy has been shown to be a safe option with proper
      patient counseling and multi-modal pain medications. In addition, same day discharge is also
      associated with decreased health care expenditures. With continued efforts to cut hospital
      costs, the pressure to discharge patients earlier continues to be high.

      The investigators propose that intravenous acetaminophen will improve post-operative pain
      control and decrease narcotic requirements for patients undergoing laparoscopic
      hysterectomies. Furthermore, The investigators expect to find decreased postsurgical nausea
      and vomiting and potentially quicker discharge to home. This could have a large impact on the
      field of gynecologic surgery as major procedures that once required overnight admission may
      now succeed at same day discharge.
    

Intervention name(s): IV acetaminophen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The patients in the treatment arm will receive 1000mg of IV acetaminophen.; The patients in the placebo arm will receive normal saline.
Other intervention name(s): OFIRMEV; Normal saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Laparoscopic Hysterectomy; IV acetaminophen; Postoperative pain control; Surgery