Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery

NCT03051932 | Withdrawn

• 1 other identifier: 16-0340
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post-thoracotomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• The amount of postoperative narcotic used.

  the amount of postoperative narcotic used, after surgery.

  Within 7 days of surgery

Secondary Outcomes (3)

• The amount of postoperative pain.

  An average of 4 days

• length of stay in the hospital

  An average of 4 days

• The amount of postoperative pain.

  Within 2-4 weeks of surgery

Study Arms (2)

Ofiramev®( IV Acetaminophen)

ACTIVE COMPARATOR

Patients randomized to the treatment arm will receive 1 g (100 mL) intravenous acetaminophen infused over 15-minutes every 6 hours for 4 doses total.

Drug: Ofiramev® (IV Acetaminophen)

Placebo IV administration

PLACEBO COMPARATOR

Patients randomized to the placebo arm will receive 100 mL of normal saline infused over 15 minutes every 6 hours for 4 doses total

Drug: Placebo IV administration

Interventions

Ofiramev® (IV Acetaminophen) DRUG

Post -op pain medication

Also known as: IV Tylenol

Ofiramev®( IV Acetaminophen)

Placebo IV administration DRUG

Post -op pain

Also known as: Normal Saline

Placebo IV administration

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-99 years
• Undergo minimally invasive thoracic surgery at UTMB
• Weight \> 50 kg
• Written informed consent obtained from subject

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Mallinckrodt: collaborator

MeSH Terms

Interventions

Acetaminophen; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ikenna Okereke, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 14, 2017
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2017-12