Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain
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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 |
- 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).
- 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.
| Estimated Enrollment: | 87 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 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 |
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 |
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| Contact: William L. Titsworth, MD, PhD | (352) 273-9000 | lee.titsworth@neurosurgery.ufl.edu |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Principal Investigator: William L. Titsworth, MD, PhD | |
| 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: | April 8, 2013 |
| 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 Postoperative Complications Pathologic Processes Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013