Pain
Conditions
Keywords
Spine surgery, Chronic pain, Opioid tolerant, Pain management in spine surgery patients
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.
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?
Interventions
DRUG150% Oral Morphine Equivalent (OME)
Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
OTHERClinical Judgment
This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
Sponsors
Allina Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 150% Oral Morphine Equivalent (OME) 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. | 45 |
| Control 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. | 55 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control | Total | 150% Oral Morphine Equivalent (OME) |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 12.6 | 51.55 years STANDARD_DEVIATION 12.15 | 51 years STANDARD_DEVIATION 11.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 55 participants | 100 participants | 45 participants |
| Sex: Female, Male Female | 32 Participants | 47 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 53 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 55 |
| serious Total, serious adverse events | 0 / 45 | 0 / 55 |
Outcome results
Primary
Immediate Postoperative Pain Control
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150% Oral Morphine Equivalent (OME) | Immediate Postoperative Pain Control | 6.6 score on a scale | Standard Deviation 2.1 |
| Control | Immediate Postoperative Pain Control | 6.8 score on a scale | Standard Deviation 1.5 |
Secondary
Pain Management Improvement at 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.
Time frame: 24 hours after the recovery period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150% Oral Morphine Equivalent (OME) | Pain Management Improvement at 24 Hours After the Recovery Period | 5.8 score on a scale | Standard Deviation 2 |
| Control | Pain Management Improvement at 24 Hours After the Recovery Period | 6.4 score on a scale | Standard Deviation 1.6 |