Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693588
• Other study ID #: 341-2012
• Status: Completed
• Phase: N/A
• First received: September 14, 2012
• Last updated: January 13, 2014
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neurosurgical Pain
• Pain
• Pain, Postoperative
• Postoperative Pain
• Surgical Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Post Operative Day 1	No
Primary	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).	Post Operative Day 3	No
Secondary	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.	Hospital discharge, an expected average of 5 days.	No