Perioperative Pain Management In Spine Surgery Patients: Part I

• Sponsor: Allina Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT01447888
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pain	Drug: 150% Oral Morphine Equivalent (OME); Other: Clinical Judgment	N/A

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?

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Perioperative Pain Management In Spine Surgery Patients: Part I
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Immediate Postoperative Pain Control [4 hours post surgery]

   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, opioid consumption, and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.

Secondary Outcome Measures

1. Pain Management Improvement at 24 Hours After the Recovery Period [24 hours after the recovery period]

   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, opioid consumption (doses and frequency), and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407

Sponsors and Collaborators

• Allina Health System

Investigators

• Principal Investigator: John P Mrachek, MD, Allina Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allina Health System
• ClinicalTrials.gov Identifier: NCT01447888
• Other Study ID Numbers: 3436-3
• First Posted: Oct 6, 2011
• Last Update Posted: Apr 27, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Allina Health System: Spine surgery; Chronic pain; Opioid tolerant; Pain management in spine surgery patients
• Additional relevant MeSH terms: Morphine

Study Results

Participant Flow

Arm/Group Title	150% Oral Morphine Equivalent (OME)	Control
Arm/Group Description	Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients 150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.	Standard perioperative dosing, which does not currently account for patients' baseline opiate use. Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
Period Title: Overall Study
STARTED	45	55
COMPLETED	45	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	150% Oral Morphine Equivalent (OME)	Control	Total
Arm/Group Description	Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients 150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.	Standard perioperative dosing, which does not currently account for patients' baseline opiate use. Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.	Total of all reporting groups
Overall Participants	45	55	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (11.7)	52 (12.6)	51.55 (12.15)
Sex: Female, Male (Count of Participants)
Female	15 33.3%	32 58.2%	47 47%
Male	30 66.7%	23 41.8%	53 53%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	45 100%	55 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Immediate Postoperative Pain Control
Description	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, opioid consumption, and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.
Time Frame	4 hours post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	150% Oral Morphine Equivalent (OME)	Control
Arm/Group Description	Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients 150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.	Standard perioperative dosing, which does not currently account for patients' baseline opiate use. Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
Measure Participants	45	55
Mean (Standard Deviation) [score on a scale]	6.6 (2.1)	6.8 (1.5)

2. Secondary Outcome

Title	Pain Management Improvement at 24 Hours After the Recovery Period
Description	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, opioid consumption (doses and frequency), and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.
Time Frame	24 hours after the recovery period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	150% Oral Morphine Equivalent (OME)	Control
Arm/Group Description	Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients 150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.	Standard perioperative dosing, which does not currently account for patients' baseline opiate use. Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
Measure Participants	45	55
Mean (Standard Deviation) [score on a scale]	5.8 (2.0)	6.4 (1.6)

Adverse Events

Time Frame	24 hours post surgery
Adverse Event Reporting Description	Safety events to be examined in this research question include incidence of aspirations, emergent intubations, oxygen desaturation events, falls, hallucinations and/or delusions, and medication errors.
Arm/Group Title	150% Oral Morphine Equivalent (OME)		Control
Arm/Group Description	Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients 150% Oral Morphine Equivalent (OME): Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.		Standard perioperative dosing, which does not currently account for patients' baseline opiate use. Clinical Judgment: This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
All Cause Mortality
	150% Oral Morphine Equivalent (OME)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	150% Oral Morphine Equivalent (OME)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	150% Oral Morphine Equivalent (OME)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.