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Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

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ClinicalTrials.gov Identifier: NCT02293525
Recruitment Status : Withdrawn (No subjects were enrolled and the sponsor suspended support at this time)
First Posted : November 18, 2014
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Vital 5, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: ReLeaf catheter Drug: Ropivacaine Drug: Saline Drug: Morphine Drug: Oxycodone Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Investigational Plan for the Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ropivacaine
Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)
Device: ReLeaf catheter
Continuous infusion rate 10ml/hr (5ml/side)

Drug: Ropivacaine
Other Name: Naropin

Drug: Morphine
Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg

Drug: Oxycodone
10mg every 4-6 hours
Other Name: Oxycontin, Roxicodone, Oxecta

Placebo Comparator: Saline
Continuous saline infusion until catheter removal (typically 36 hours)
Device: ReLeaf catheter
Continuous infusion rate 10ml/hr (5ml/side)

Drug: Saline
Drug: Morphine
Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg

Drug: Oxycodone
10mg every 4-6 hours
Other Name: Oxycontin, Roxicodone, Oxecta




Primary Outcome Measures :
  1. Pain (Mean VAS pain score at 24 hours post-procedure) [ Time Frame: 24 hours ]
    Mean VAS pain score at 24 hours post-procedure


Secondary Outcome Measures :
  1. Medication Use [ Time Frame: 3 months ]
    Narcotic use from surgery through 3 months post-operative

  2. Adverse Events [ Time Frame: 3 months ]
    Occurrence of adverse events through 3 months post-operative


Other Outcome Measures:
  1. Length of Hospital Stay [ Time Frame: Discharge, on average 2 to 3 days ]
    Time from surgery to hospital discharge, on average 2 to 3 days

  2. Incisional Pain [ Time Frame: 3 months ]
    Pain at the site of the incision at 3 months post-operative

  3. Incidence of nausea and vomiting [ Time Frame: Discharge, on average 2 to 3 days ]
    Occurrence of nausea with or without vomiting and treatments from time of surgery through hospital discharge (which is 2-3 days on average)

  4. Time of Foley Catheter Removal [ Time Frame: Discharge, on average 2 to 3 days ]
    Time foley catheter was removed following surgery but no later than hospital discharge (which is 2-3 days on average)

  5. Time to First Ambulate [ Time Frame: Discharge, on average 2 to 3 days ]
    Time to walk following surgery but no later than hospital discharge (which is 2-3 days on average)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
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Responsible Party: Vital 5, LLC
ClinicalTrials.gov Identifier: NCT02293525     History of Changes
Other Study ID Numbers: CLI-001-0201
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Oxycodone
Ropivacaine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics