Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter & wound drain in patients following lumbar spinal fusion surgery. One half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.

Detailed Description
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Posterior lumbar spinal fusion is commonly used in the management of a wide array of spinal disorders ranging from instability to degenerative disc disease. However, severe postoperative pain is a significant adverse outcome in patients who have undergone a lumbar spinal fusion procedure. This pain may delay mobilization and decrease compliance with physical, occupational, or pulmonary physiotherapy. Pain symptoms may worsen with activity and ambulation due to reflex spasms of the paraspinal muscles elicited by pain from the wound. A local anesthetic agent administered immediately after surgery into the tissue surrounding the wound addresses the pain source for less than four hours. Therefore, it is reasonable to consider continuous local anesthetic infusion, which may limit local pain mediators for a longer duration. Continuous local anesthetic infusion into the paraspinal musculature with the ReLeaf catheter has the potential to reduce pain, narcotic demand & usage, and accelerate the rate of recovery in lumbar spinal fusion patients.

Official Title
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Investigational Plan for the Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: ReLeaf catheter
* Drug: Ropivacaine
* Drug: Saline
* Drug: Morphine
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature Diagnosis of lumbar spine disease requiring an open, midline, instrumented posterolateral fusion with or without interbody support at one or two vertebral levels and laminectomy or laminotomy Physically and mentally willing to comply with the study requirements Signed the study informed consent Exclusion Criteria: Lumbar spine disease requiring more than two levels of instrumentation Any previous operative lumbar procedure, except discectomy or hemi-laminotomy performed a minimum of 2 years prior to current study surgery Patients requiring iliac crest bone graft for the procedure Intra-operative durotomy Any duration of pre-operative morphine or morphine equivalent use exceeding 30 mg of morphine equivalents per day for longer than 3 months Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse) Diagnosed with Severe Depression and on treatment Active infection at the operative level or a symptomatic infection Diagnosed systemic disease that would affect the subject's welfare or overall outcome of the research study (i.e. Paget's disease, renal osteodystrophy, Lupus etc) Is pregnant or breast feeding Has any active malignancy or spinal arthrodesis being performed for a tumor decompression Has a known allergy to local analgesics Pending litigation related to back pain or injury or Worker's Compensation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine<br>Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours) | Device: ReLeaf catheter<br>* Continuous infusion rate 10ml/hr (5ml/side)<br>Drug: Ropivacaine<br> <br> * Other names: Naropin;Drug: Morphine<br>* Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg<br>Drug: Oxycodone<br>* 10mg every 4-6 hours<br>* Other names: Oxycontin, Roxicodone, Oxecta;|
| Placebo Comparator: Saline<br>Continuous saline infusion until catheter removal (typically 36 hours) | Device: ReLeaf catheter<br>* Continuous infusion rate 10ml/hr (5ml/side)<br>Drug: Saline<br> <br> Drug: Morphine<br>* Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg<br>Drug: Oxycodone<br>* 10mg every 4-6 hours<br>* Other names: Oxycontin, Roxicodone, Oxecta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Mean VAS pain score at 24 hours post-procedure) | Mean VAS pain score at 24 hours post-procedure | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Use | Narcotic use from surgery through 3 months post-operative | 3 months | 
| Adverse Events | Occurrence of adverse events through 3 months post-operative | 3 months |