Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery

• Status: Withdrawn
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100 patients, 50 per treatment arm, undergoing minimally invasive thoracic surgery will be randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL) plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: Mallinckrodt
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Age 18-99 years

• Undergo minimally invasive thoracic surgery at UTMB

• Weight > 50 kg

• Written informed consent obtained from subject

Exclusion Criteria:

• Hepatic dysfunction

• Renal dysfunction

• Chronic alcohol consumption

• Acetaminophen sensitivity

• Opioid tolerance

• History of chronic pain

• Vulnerable populations including pregnant and prisoners

• Extension into an extrathoracic compartment (i.e. minimally invasive esophagectomy), or concomitant chest wall resection