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

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acetaminophen or Placebo

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring acetaminophen, pain, laminectomy, craniotomy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Brooke Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Acetaminophen & Craniotomy

Placebo & Craniotomy

Acetaminophen & Laminectomy

Placebo & Laminectomy

Arm Description

Drug: Acetaminophen 1000mg administered intravenously during craniotomy

Placebo administered intravenously during craniotomy.

Acetaminophen 1000mg administered intravenously during laminectomy.

Placebo administered during laminectomy.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03261310

First Posted

April 23, 2014

Last Updated

August 23, 2017

Sponsor

Brooke Army Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03261310

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brooke Army Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

acetaminophen, pain, laminectomy, craniotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acetaminophen & Craniotomy

Arm Type

Experimental

Arm Description

Drug: Acetaminophen 1000mg administered intravenously during craniotomy

Arm Title

Placebo & Craniotomy

Arm Type

Placebo Comparator

Arm Description

Placebo administered intravenously during craniotomy.

Arm Title

Acetaminophen & Laminectomy

Arm Type

Experimental

Arm Description

Acetaminophen 1000mg administered intravenously during laminectomy.

Arm Title

Placebo & Laminectomy

Arm Type

Placebo Comparator

Arm Description

Placebo administered during laminectomy.

Intervention Type

Drug

Intervention Name(s)

Acetaminophen or Placebo

Intervention Description

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".

Primary Outcome Measure Information:

Title

Pain Scores

Description

Time Frame

1hour -6 hours

Secondary Outcome Measure Information:

Title

Opioid administration

Description

Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.

Time Frame

1 hour-6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dimitar Dentchev, MD

Phone

210-916-2118

dimitar.i.dentchev.civ@mail.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dimitar Dentchev, MD

Organizational Affiliation

BAMC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Betsy Murray, MD

Organizational Affiliation

BAMC

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Robert Vietor, MD

Organizational Affiliation

BAMC

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jonathan Deeth, MD

Organizational Affiliation

BAMC

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Daniel Stypula, DO

Organizational Affiliation

BAMC

Official's Role

Study Chair

Facility Information:

Facility Name

Brooke Army Medical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dimitar Dentchev, MD

Phone

210-916-2118

dimitar.i.dentchev.civ@mail.mil

First Name & Middle Initial & Last Name & Degree

Dimitar Dentchev, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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