Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study
NCT ID: NCT02202369
Last Updated: 2025-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE4
50 participants
INTERVENTIONAL
2015-06-25
2050-12-31
Brief Summary
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Detailed Description
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Controlling postoperative pain is a critical first step in facilitating a patient's recovery and improved quality of life. In-hospital pain levels will be measured using a numeric pain scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard of care protocol. Assessments are every four to six hours, within 60 minutes after receiving a pain medication
Hypothesis: Patients treated with the MMA pain protocol will have significantly less immediate postoperative pain as compared to patients treated with the standard pain protocol.
Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Decreasing narcotic consumption following lumbar spinal fusion surgery is important for faster recovery for the patient, decreasing narcotic related side effects (nausea and vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount of narcotic use during the course of the hospitalization for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents.
Hypothesis: Patients treated with the MMA pain protocol will consume significantly less immediate postoperative narcotic pain medications compared to patients treated with the standard pain protocol.
Specific Aim #3: To compare the length of hospital stay of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
Decreasing the amount of time patients remain in the hospital may decrease the time it takes a patient to return to personal and societal responsibilities. Additionally it reduces the patients risk of a nosocomial infection and reduces the costs of the surgery.
Hypothesis: Patients treated with the MMA pain protocol will have a significantly reduced length of stay in the hospital compared to patients treated with the standard pain protocol.
Specific Aim #4: To compare postoperative quality of life of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol.
The primary purpose of lumbar fusion surgery is to improve the quality of life for patients. The Oswestry Disability Index (ODI) will be used as a disease specific measure. The Veterans Rand 12 (VR-12) will be used as a general health outcome measure. Each of these patient reported outcome measures will be collected pre-operatively and at each of the following postoperative visits: 2 weeks, 6 weeks, 3 month, 6 visit, 1 visit, and 2 year.
Hypothesis: Patients treated with the MMA pain protocol will have significantly greater improvement in Quality of Life measures compared to patients treated with the standard pain protocol and this will be sustained out to two years post-operatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multimodal Analgesia (MMA) Treatment
Multimodal Analgesia Treatment
Subjects are given medications preop (Pregabalin, Oxycodone, Acetaminophen, Transdermal Scopolamine, Cyclobenzaprine), intraop (Propofol induction, Sevoflorane maintenance, Dexamethasone, Fentanyl, Ketamine, Marcaine, Zofran) and postop(Acetaminophen, Pregabalin, Tramadol, Cyclobenzaprine) that implement a multi-modal approach to managing pain.
Standard of Care Pain Managment Protocol
Standard of Care Pain Management Protocol
Subjects will be treated with patient controlled (standard of care) narcotic analgesia for pain management. (Marcaine, Dexamethasone, Zofran, Morphine, Acetaminophen, Cyclobenzaprine)
Interventions
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Multimodal Analgesia Treatment
Subjects are given medications preop (Pregabalin, Oxycodone, Acetaminophen, Transdermal Scopolamine, Cyclobenzaprine), intraop (Propofol induction, Sevoflorane maintenance, Dexamethasone, Fentanyl, Ketamine, Marcaine, Zofran) and postop(Acetaminophen, Pregabalin, Tramadol, Cyclobenzaprine) that implement a multi-modal approach to managing pain.
Standard of Care Pain Management Protocol
Subjects will be treated with patient controlled (standard of care) narcotic analgesia for pain management. (Marcaine, Dexamethasone, Zofran, Morphine, Acetaminophen, Cyclobenzaprine)
Eligibility Criteria
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Inclusion Criteria
2. \> 18 years of age and \< 70 years of age
3. The subject is willing and able to understand, sign and date the study specific patient informed consent and HIPAA authorization to volunteer participation in the study
Exclusion Criteria
2. Patients with renal disease (documented glomerular filtration rate \< 60mL/min/1.73m2)
3. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.
4. Patients with active alcohol dependence
5. Patients with active illicit drug dependence
6. Patients \< 18 years of age and \>70 years of age
7. Patients allergic to any medication given in either arm (list medications)
8. Patients who have a seizure disorder
18 Years
ALL
No
Sponsors
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Charlotte Orthopedic Hospital
OTHER
OrthoCarolina Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Alden Milam, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoCarolina Research Institute, Inc.
Locations
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OrthoCarolina
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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9080
Identifier Type: -
Identifier Source: org_study_id
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