Perioperative Pain Management In Spine Surgery Patients: Part I

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Abbott Northwestern Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Allina Hospitals and Clinics
Information provided by (Responsible Party):
John Mrachek, MD, Abbott Northwestern Hospital
ClinicalTrials.gov Identifier:
NCT01447888
First received: September 22, 2011
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

The purpose of this study is a comparison of pain management in opioid-tolerant spine surgery patients using a perioperative dosing goal of 150% of patient's baseline oral morphine equivalent (OME), as compared to standard perioperative dosing, which does not currently account for patients' baseline opiate use.


Condition Intervention
Pain
Drug: 150% Oral Morphine Equivalent (OME)
Other: Clinical Judgment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Perioperative Pain Management In Spine Surgery Patients: Part I

Resource links provided by NLM:


Further study details as provided by Abbott Northwestern Hospital:

Primary Outcome Measures:
  • Immediate postoperative pain control [ Time Frame: 4 hours post surgery ] [ Designated as safety issue: No ]
    We will be assessing if the intervention improves immediate (4 hours) postoperative pain control as compared to the non-intervention group. Measures that will be used to assess immediate post-operative pain include: Verbal pain scores, non-verbal pain scores, opioid consumption, and vital signs.


Secondary Outcome Measures:
  • Pain management improvement at 24 hours after the recovery period [ Time Frame: 4 hours post surgery (recovery period) and 24 hours after the recovery period ] [ Designated as safety issue: No ]
    We will be assessing if the intervention improved postoperative pain management during the first 24 hours after the recovery period (first 4 hours postoperatively) as compared to the non-intervention group. Measures that will be used to assess success: Verbal pain scores, patients reaching pain goals, opioid consumption (doses and frequency), and vital signs.


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 150% Oral Morphine Equivalent (OME)
Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients
Drug: 150% Oral Morphine Equivalent (OME)
Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
Active Comparator: Control
Standard perioperative dosing, which does not currently account for patients' baseline opiate use.
Other: Clinical Judgment
This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.

Detailed Description:

Spine surgery patients experience high levels of pain and report poor pain management in patient satisfaction surveys. Data examined from Allina HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) pain management questions indicate that spine surgery patients report poor pain management. In July, August, and September 2010 patients on the Abbott Northwestern (ANW) spine surgery unit reported 62% on the composite pain score compared to 69% to 71% for ANW overall. During these same three months, the proportion of patients on this unit reporting their pain was always well controlled ranged from 49% to 57% compared to 59% to 64% for the hospital overall. Since ANW serves a high number of spine surgery patients, this poor pain management reporting is a concern for patient care and possibly for future Medicare/Medicaid funding formulas.

Opioid-tolerant patients pose a particular challenge to pain management. The intervention to be tested specifically targets patients who are determined to be opioid-tolerant patients. Opioid-tolerant patients are generally patients who have severe chronic pain, and, thus, are taking pain medication regularly. Tolerance occurs when chronic exposure to a drug diminishes its analgesic effect or creates the need for a higher dose to maintain this effect. Given the severe chronic pain conditions of many patients who are presenting for spine surgery, there is a high level of opioid tolerance among these patients.

While there is no agreed upon definition in the literature about a fixed opioid amount that constitutes "opioid tolerance," Abbott Northwestern Hospital has a working definition of opioid tolerant patients as those who are receiving ≥ 20 mg of oxycodone (or equivalent)/day for > 7 days. This definition is slightly more aggressive than the Institute of Safe Medication Practices definition which set the standard at "at least 30 mg oxycodone/day for greater than a week."

While higher postoperative pain status has been documented in opioid-tolerant patients, very little has been done to examine customizing perioperative opioid dosing to improve pain management in this population. The proposed intervention is designed specifically to test if post-operative pain management can be improved in opioid-tolerant patients using perioperative goal-directed parenteral opioid dosing based on 150% of the patient's baseline oral morphine equivalent (OME). It is important to note this method of perioperative goal-directed parenteral opioid dosing has been used at ANW on spine surgery patients, based on clinical decision of the anesthesiologist. However, this strategy has not been tested compared to standard care.

For this study our research questions are:

  1. Does the intervention improve immediate (4 hours) post-operative pain over the comparison group?
  2. Does the intervention improve management during the 24 hours (or at discharge) after the recovery period over the comparison group?
  3. Is the clinical intervention associated with selected improved post-operative status measures compared to the control group?
  4. Is the clinical intervention associated with long-term differences in reported pain scores or medication levels as measured by a phone call at 4 weeks after surgery?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be 18 years or older.
  2. Patients must be undergoing spine surgery at ANW.
  3. Patients must be assessed to be opioid tolerant based on the established criteria.
  4. Patients must be willing and able to provide written informed consent.

Exclusion Criteria:

  1. Patients unwilling to comply with research procedures.
  2. Patients having surgery for correction of scoliosis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447888

Contacts
Contact: Amy M Schrecengost, BS, CCRC 612-262-4921 amy.schrecengost@allina.com

Locations
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Amy Schrecengost    612-262-4921    amy.schrecengost@allina.com   
Sponsors and Collaborators
Abbott Northwestern Hospital
Allina Hospitals and Clinics
Investigators
Principal Investigator: John P Mrachek, MD Abbott Northwestern Hospital
  More Information

No publications provided

Responsible Party: John Mrachek, MD, Anesthesiologist, Director of Abbott Northwestern Hospital's Acute Pain Service, Abbott Northwestern Hospital
ClinicalTrials.gov Identifier: NCT01447888     History of Changes
Other Study ID Numbers: 3436-3
Study First Received: September 22, 2011
Last Updated: October 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Northwestern Hospital:
Spine surgery
Chronic pain
Opioid tolerant
Pain management in spine surgery patients

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 23, 2014