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Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01693588
First received: September 14, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Pain
Postoperative Pain
Surgical Pain
Neurosurgical Pain
Other: Pain Management Bundle

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Mean Score on the Visual Analogue Scale [ Time Frame: Post Operative Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post Operative Day 3 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Hospital discharge, an expected average of 5 days. ] [ Designated as safety issue: No ]
    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.


Enrollment: 94
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain Management Bundle
The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.
Other: Pain Management Bundle
The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693588

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: William L. Titsworth, MD, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01693588     History of Changes
Other Study ID Numbers: 341-2012
Study First Received: September 14, 2012
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Pain
Postoperative Pain
Surgical Pain
Neurosurgical Pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014