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

NCT03261310 | Unknown DMC

• 1 other identifier: 386486-1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

acetaminophen; pain; laminectomy; craniotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Opioid administration

  1 hour-6 hours

Study Arms (4)

Acetaminophen & Craniotomy

EXPERIMENTAL

Drug: Acetaminophen 1000mg administered intravenously during craniotomy

Drug: Acetaminophen or Placebo

Placebo & Craniotomy

PLACEBO COMPARATOR

Placebo administered intravenously during craniotomy.

Drug: Acetaminophen or Placebo

Acetaminophen & Laminectomy

EXPERIMENTAL

Acetaminophen 1000mg administered intravenously during laminectomy.

Drug: Acetaminophen or Placebo

Placebo & Laminectomy

PLACEBO COMPARATOR

Placebo administered during laminectomy.

Drug: Acetaminophen or Placebo

Interventions

Acetaminophen or Placebo DRUG

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".

Acetaminophen & Craniotomy; Acetaminophen & Laminectomy; Placebo & Craniotomy; Placebo & Laminectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dimitar Dentchev, MD

  BAMC

  PRINCIPAL INVESTIGATOR

• Betsy Murray, MD

  BAMC

  STUDY CHAIR

• Robert Vietor, MD

  BAMC

  STUDY CHAIR

• Jonathan Deeth, MD

  BAMC

  STUDY CHAIR

• Daniel Stypula, DO

  BAMC

  STUDY CHAIR

Central Study Contacts

Dimitar Dentchev, MD

CONTACT

210-916-2118; dimitar.i.dentchev.civ@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: August 25, 2017
• Study Start: May 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

US (1)