Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery

The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Acetaminophen or Placebo

Detailed Description

The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78234
      • Recruiting
      • Brooke Army Medical Center
      • Contact: Dimitar Dentchev, MD; Phone Number: 210-916-2118; Email: dimitar.i.dentchev.civ@mail.mil
      • Principal Investigator: Dimitar Dentchev, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-90 years old
• undergoing non-emergent craniotomy or single level lumbar laminectomy
• must be able to rate pain on a 0-10 scale post-operatively

Exclusion Criteria:

• history of liver disease
• allergy to acetaminophen
• age less than 18 years
• renal failure with creatinine clearance less than 30
• pregnancy
• altered mentation with inability to report pain score
• patients who have received acetaminophen within 6 hours of surgery
• patients in which a neuraxial technique has been performed for surgery
• prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen & Craniotomy; Drug: Acetaminophen 1000mg administered intravenously during craniotomy	Drug: Acetaminophen or Placebo; Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Placebo Comparator: Placebo & Craniotomy; Placebo administered intravenously during craniotomy.	Drug: Acetaminophen or Placebo; Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Experimental: Acetaminophen & Laminectomy; Acetaminophen 1000mg administered intravenously during laminectomy.	Drug: Acetaminophen or Placebo; Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".
Placebo Comparator: Placebo & Laminectomy; Placebo administered during laminectomy.	Drug: Acetaminophen or Placebo; Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours).	1hour -6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid administration	Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.	1 hour-6 hours

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Dimitar Dentchev, MD, BAMC; Study Chair: Betsy Murray, MD, BAMC; Study Chair: Robert Vietor, MD, BAMC; Study Chair: Jonathan Deeth, MD, BAMC; Study Chair: Daniel Stypula, DO, BAMC

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: pain; acetaminophen; craniotomy; laminectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 386486-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED