PainNCT01447888
Perioperative Pain Management In Spine Surgery Patients: Part I
A study testing 150% Oral Morphine Equivalent (OME) and Clinical Judgment in people with Pain, run by Allina Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- 150% Oral Morphine Equivalent (OME) and Clinical Judgment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years or older.
- Patients must be undergoing spine surgery at ANW.
- Patients must be assessed to be opioid tolerant based on the established criteria.
- Patients must be willing and able to provide written informed consent.
Who cannot join
- Patients unwilling to comply with research procedures.
- Patients having surgery for correction of scoliosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
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.
Read the 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:
- Does the intervention improve immediate (4 hours) post-operative pain over the comparison group?
- Does the intervention improve management during the 24 hours (or at discharge) after the recovery period over the comparison group?
- Is the clinical intervention associated with selected improved post-operative status measures compared to the control group?
- 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?
- Conditions
- Pain
- Being tested
- 150% Oral Morphine Equivalent (OME), Clinical Judgment
- Keywords
- Spine surgery, Chronic pain, Opioid tolerant, Pain management in spine surgery patients
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150% Oral Morphine Equivalent (OME)Drug
Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
Clinical JudgmentOther
This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| 150% Oral Morphine Equivalent (OME) | Experimental | Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients Receives: Drug: 150% Oral Morphine Equivalent (OME) |
| Control | Active comparator | Standard perioperative dosing, which does not currently account for patients' baseline opiate use. Receives: Other: Clinical Judgment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours post surgery
Secondary outcomes (1)
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.
Measured: 24 hours after the recovery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Mrachek, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447888
- Sponsor's protocol ID
- 3436-3
- Status last verified
- Apr 2020
- First submitted
- 22 Sep 2011
- Last updated
- 27 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pain Management In Spine Surgery Patients: Part I
- ClinicalTrials.gov ID
- NCT01447888
- Acronym / sponsor ID
- 3436-3
- Conditions
- Pain
- Keywords
- Spine surgery, Chronic pain, Opioid tolerant, Pain management in spine surgery patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Posted 27 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the intervention improve immediate (4 hours) post-operative pain over the comparison group?
- Does the intervention improve management during the 24 hours (or at discharge) after the recovery period over the comparison group?
- Is the clinical intervention associated with selected improved post-operative status measures compared to the control group?
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150% Oral Morphine Equivalent (OME) | Experimental | Drug: 150% Oral Morphine Equivalent (OME)Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients |
| Control | Active comparator | Other: Clinical JudgmentStandard perioperative dosing, which does not currently account for patients' baseline opiate use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be 18 years or older.
- Patients must be undergoing spine surgery at ANW.
- Patients must be assessed to be opioid tolerant based on the established criteria.
- Patients must be willing and able to provide written informed consent.
Key exclusion criteria (2 listed)
- Patients unwilling to comply with research procedures.
- Patients having surgery for correction of scoliosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150% Oral Morphine Equivalent (OME)Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl. | Drug | 150% Oral Morphine Equivalent (OME) |
| Clinical JudgmentThis method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist. | Other | Control |
Primary outcome
Immediate Postoperative Pain Control
Time frame: 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.
1 secondary outcome
Pain Management Improvement at 24 Hours After the Recovery Period
Time frame: 24 hours after the recovery period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Mrachek, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 150% Oral Morphine Equivalent (OME) and Clinical Judgment in people with Pain, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Postoperative Pain Control (time frame: 4 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.