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Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

Primary Purpose

Pain, Postoperative Pain, Surgical Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Management Bundle
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Pain, Postoperative Pain, Surgical Pain, Neurosurgical Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Postoperative neurosurgical patient treated at the University of Florida
  • Primary language is English

Exclusion Criteria:

  • Younger than 18 or older than 100 years of age
  • Patients who are pregnant, wards of the state, prisoners, and patients who lack the ability to communicate their pain level

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain Management Bundle

Arm Description

The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.

Outcomes

Primary Outcome Measures

Mean Score on the Visual Analogue Scale
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
Mean Score on the Visual Analogue Scale
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).

Secondary Outcome Measures

Score on the HCAHP survey.
The HCAHP survey measures how often patients perceived an aspect of their care was performed, generally using a scale of always, usually, sometimes, and never.

Full Information

First Posted
September 14, 2012
Last Updated
January 13, 2014
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01693588
Brief Title
Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain
Official Title
The Effect of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
High levels of postoperative pain are associated with an increased risk of lung and heart complications, are the most common reason for delayed discharge or for unexpected hospital admission after ambulatory surgery, and are responsible for prolonged recovery after inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight gain and may have an impact on the patient's nutrition post operatively. The purpose of this study is to evaluate the effectiveness of a multimodality pain management protocol on postoperative neurosurgical pain.
Detailed Description
Despite the long-standing recognition of postoperative pain as both prevalent and undertreated, 20% to 30% of all surgical patients continue to experience moderate to severe postoperative pain. High levels of postoperative pain are associated with an increased risk of pulmonary and cardiovascular complications, are the most common reason for delayed discharge or for unexpected hospital admission after ambulatory surgery, and are responsible for prolonged convalescence after inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight gain and may have an impact on the patient's nutrition post operatively. Finally, high levels of postoperative pain have also been associated with an increased risk of chronic pain. Therefore, the aggressive treatment of postoperative pain may be particularly important in influencing patient outcomes, inadvertent readmissions, and propensity for developing chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Pain, Surgical Pain, Neurosurgical Pain
Keywords
Pain, Postoperative Pain, Surgical Pain, Neurosurgical Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Management Bundle
Arm Type
Experimental
Arm Description
The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.
Intervention Type
Other
Intervention Name(s)
Pain Management Bundle
Intervention Description
The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.
Primary Outcome Measure Information:
Title
Mean Score on the Visual Analogue Scale
Description
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
Time Frame
Post Operative Day 1
Title
Mean Score on the Visual Analogue Scale
Description
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
Time Frame
Post Operative Day 3
Secondary Outcome Measure Information:
Title
Score on the HCAHP survey.
Description
The HCAHP survey measures how often patients perceived an aspect of their care was performed, generally using a scale of always, usually, sometimes, and never.
Time Frame
Hospital discharge, an expected average of 5 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postoperative neurosurgical patient treated at the University of Florida Primary language is English Exclusion Criteria: Younger than 18 or older than 100 years of age Patients who are pregnant, wards of the state, prisoners, and patients who lack the ability to communicate their pain level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William L. Titsworth, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26967774
Citation
Titsworth WL, Abram J, Guin P, Herman MA, West J, Davis NW, Bushwitz J, Hurley RW, Seubert CN. A prospective time-series quality improvement trial of a standardized analgesia protocol to reduce postoperative pain among neurosurgery patients. J Neurosurg. 2016 Dec;125(6):1523-1532. doi: 10.3171/2015.10.JNS15698. Epub 2016 Mar 11.
Results Reference
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Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

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