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Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

Primary Purpose

Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ReLeaf catheter
Ropivacaine
Saline
Morphine
Oxycodone
Sponsored by
Vital 5, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Ropivacaine

    Saline

    Arm Description

    Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)

    Continuous saline infusion until catheter removal (typically 36 hours)

    Outcomes

    Primary Outcome Measures

    Pain (Mean VAS pain score at 24 hours post-procedure)
    Mean VAS pain score at 24 hours post-procedure

    Secondary Outcome Measures

    Medication Use
    Narcotic use from surgery through 3 months post-operative
    Adverse Events
    Occurrence of adverse events through 3 months post-operative

    Full Information

    First Posted
    October 27, 2014
    Last Updated
    January 20, 2016
    Sponsor
    Vital 5, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02293525
    Brief Title
    Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
    Official Title
    Investigational Plan for the Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No subjects were enrolled and the sponsor suspended support at this time
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vital 5, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ropivacaine
    Arm Type
    Active Comparator
    Arm Description
    Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)
    Arm Title
    Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Continuous saline infusion until catheter removal (typically 36 hours)
    Intervention Type
    Device
    Intervention Name(s)
    ReLeaf catheter
    Intervention Description
    Continuous infusion rate 10ml/hr (5ml/side)
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    Naropin
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Intervention Description
    Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone
    Other Intervention Name(s)
    Oxycontin, Roxicodone, Oxecta
    Intervention Description
    10mg every 4-6 hours
    Primary Outcome Measure Information:
    Title
    Pain (Mean VAS pain score at 24 hours post-procedure)
    Description
    Mean VAS pain score at 24 hours post-procedure
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Medication Use
    Description
    Narcotic use from surgery through 3 months post-operative
    Time Frame
    3 months
    Title
    Adverse Events
    Description
    Occurrence of adverse events through 3 months post-operative
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    Length of Hospital Stay
    Description
    Time from surgery to hospital discharge, on average 2 to 3 days
    Time Frame
    Discharge, on average 2 to 3 days
    Title
    Incisional Pain
    Description
    Pain at the site of the incision at 3 months post-operative
    Time Frame
    3 months
    Title
    Incidence of nausea and vomiting
    Description
    Occurrence of nausea with or without vomiting and treatments from time of surgery through hospital discharge (which is 2-3 days on average)
    Time Frame
    Discharge, on average 2 to 3 days
    Title
    Time of Foley Catheter Removal
    Description
    Time foley catheter was removed following surgery but no later than hospital discharge (which is 2-3 days on average)
    Time Frame
    Discharge, on average 2 to 3 days
    Title
    Time to First Ambulate
    Description
    Time to walk following surgery but no later than hospital discharge (which is 2-3 days on average)
    Time Frame
    Discharge, on average 2 to 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16261108
    Citation
    Yukawa Y, Kato F, Ito K, Terashima T, Horie Y. A prospective randomized study of preemptive analgesia for postoperative pain in the patients undergoing posterior lumbar interbody fusion: continuous subcutaneous morphine, continuous epidural morphine, and diclofenac sodium. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2357-61. doi: 10.1097/01.brs.0000184377.31427.fa.
    Results Reference
    background
    PubMed Identifier
    15220788
    Citation
    Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, Hansen-Algenstedt N, Weisner L, Staude HJ, Standl T. Quality of postoperative pain using an intraoperatively placed epidural catheter after major lumbar spinal surgery. Anesthesiology. 2004 Jul;101(1):175-80. doi: 10.1097/00000542-200407000-00027.
    Results Reference
    background
    PubMed Identifier
    14693613
    Citation
    Bianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B, Guberti A, Massari L. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004 Jan;98(1):166-172. doi: 10.1213/01.ANE.0000093310.47375.44.
    Results Reference
    background
    PubMed Identifier
    18197109
    Citation
    Elder JB, Hoh DJ, Wang MY. Postoperative continuous paravertebral anesthetic infusion for pain control in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2008 Jan 15;33(2):210-8. doi: 10.1097/BRS.0b013e318160447a.
    Results Reference
    background

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    Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

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