Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Intravenous Acetaminophen
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 580.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Some patients have respiratory depression (decreased breaths per minute) after surgery.
      Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this
      study is to determine if acetaminophen decreases respiratory depression after surgery. The
      investigators will also evaluate the cost effectiveness of acetaminophen.

      Patients having elective major abdominal surgery are being asked to participate in this
      research study. If eligible, a patient will have their baseline tidal volume (amount of air
      moved into or out of the lungs) and vital capacity (how much air the lungs are capable of
      holding) measured using a spirometer (apparatus for measuring the volume of air inspired and
      expired by the lungs) measured before surgery. Three questionnaires will also need to be
      completed before surgery.

      The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or
      placebo (inactive substance) as an infusion throughout surgery and for the first two days
      thereafter. Neither the patient nor his or her physician will know if the patient is assigned
      to study drug or placebo. Regardless of study assignment, both groups will receive standard
      pain management medications and sedation.

      After surgery, the patient's blood pressure, activity, posture, respiratory rate, the
      electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and
      respiratory rate will be continuously monitored and recorded for 48 hours using a wireless
      pulse-oximeter and a respiratory volume monitor.

      48 hours after surgery the patient will be asked to complete a patient satisfaction
      questionnaire, which will allow the patient to rate the satisfaction with the treatment
      received for pain. The patient will also be asked to complete a questionnaire about recovery.

      At discharge, the patient will be given two questionnaires about pain and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  18-85 years old

          -  above 50 kg

          -  American Society of Anaesthesiologists Physical Status 1-3

          -  Scheduled for elective open or laparoscopic abdominal surgery, including colorectal,
             prostate, and hysterectomy surgeries

          -  Patients with anticipated hospitalization of two nights

          -  Expected to require parenteral opioids for at least 48 hours for postoperative pain

          -  Able to use IV Patient-Controlled Analgesia systems

        Exclusion Criteria:

          -  Hepatic disease, e.g. twice the normal levels of liver enzymes

          -  Kidney disease, e.g. twice the normal level of serum creatinine

          -  Epidural analgesia or regional blocks (including Transverse abdominis plane block)

          -  Acetaminophen sensitivity or known allergy

          -  Female patients who are pregnant or breastfeeding

          -  Patients taking warfarin