IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kathirvel Subramaniam
• Collaborator: Mallinckrodt
• Treatments: Acetaminophen

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.