Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

January 13, 2014 updated by: University of Florida

The Effect of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score on the Visual Analogue Scale
Time Frame: Post Operative Day 1
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
Post Operative Day 1
Mean Score on the Visual Analogue Scale
Time Frame: Post Operative Day 3
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
Post Operative Day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on the HCAHP survey.
Time Frame: Hospital discharge, an expected average of 5 days.
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.
Hospital discharge, an expected average of 5 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: William L. Titsworth, MD, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 341-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Pain Management Bundle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe