Mallinckrodt Pharmaceuticals has awarded Duke Anesthesiology’s Dr. Jeffrey Gadsden $199,734 in funding for a clinical trial titled, “Comparison of Multimodal Analgesic Regimen with Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial.”
Little robust data exists comparing the efficacy of oral versus intravenous acetaminophen for postoperative pain following major surgical procedures such as joint replacement. In this double-blind, randomized controlled trial, Dr. Gadsden’s hypothesis is that use of the intravenous formulation will result in a 20 percent reduction in opioid consumption in the first 24 hours.
60 patients scheduled for primary total hip arthroplasty will be enrolled in this trial. Subjects will receive a standardized anesthetic and postoperative analgesic regimen, and prior to surgery will be randomized to receive four doses of acetaminophen every six hours either by the oral or intravenous route. Placebo controls will ensure blinding. Subjects will be evaluated while in hospital for pain scores, satisfaction, opioid use, and rehab outcomes such as range of motion and ability to sit, stand, and walk in the postoperative period. Other outcomes will include total hospital cost, pharmacy-related costs, costs due to opioid-related adverse events, hospital length of stay (raw and criteria-based readiness) and ER presentations/admissions due to pain in the first 30 days.
Dr. Gadsden is an associate professor of anesthesiology and chief of Duke Anesthesiology’s Division of Orthopaedics, Plastics and Regional Anesthesiology. He’s also the associate director of the department’s Regional Anesthesiology and Acute Pain Medicine Fellowship.