IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population
Condition: Abdominal Wall Hernia; Pancreatic Diseases; Bowel Disease; Gastric Disease
MeSH terms: Pancreatic Diseases; Stomach Diseases; Hernia, Abdominal; Hernia, Ventral; Internal Hernia
Intervention: Acetaminophen Injectable Product; Sodium Chloride 0.9%, Intravenous
Intervention description: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively; The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participant, care provider, outcomes assessor and investigator are all blinded to the treatment allocation
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post-operative pain; Major abdominal surgery; Colorectal surgery; Gastric surgery

Summary:

      Number of patients with unsatisfactory pain relief defined as average visual analog scale
      (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48
      hours postoperative period will be compared between the two groups and form the primary
      outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale
      (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both
      groups will also be evaluated by the amount of total narcotic consumption (measured with IV
      morphine equivalent doses of analgesics used to provide pain relief).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  18 years of age or older

          -  patients scheduled for elective colorectal, pancreatic, and other major abdominal
             procedure.

          -  Patient consent will be obtained preoperatively for eligible study participants.

        Exclusion Criteria:

          -  Patients who refuse to participate in the study or part of any other enhanced recovery
             after surgery (ERAS) research protocol.

          -  Patients with a documented allergy to acetaminophen.

          -  Chronic alcoholism

          -  Hypovolemia

          -  Chronic malnutrition

          -  Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min)
             or hemodialysis

          -  Patients with a history of hepatic impairment, history of hepatic impairment or active
             hepatic disease

          -  severe chronic pain condition that required daily preoperative opioid dependence

          -  Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding
             accurate assessment of pain scores or other study measures will be excluded.