Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

NCT02293525 | Withdrawn

• 1 other identifier: CLI-001-0201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

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

  Mean VAS pain score at 24 hours post-procedure

  24 hours

Secondary Outcomes (2)

• Medication Use

  3 months

• Adverse Events

  3 months

Other Outcomes (5)

• Length of Hospital Stay

  Discharge, on average 2 to 3 days

• Incisional Pain

  3 months

• Incidence of nausea and vomiting

  Discharge, on average 2 to 3 days

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

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

Device: ReLeaf catheter; Drug: Ropivacaine; Drug: Morphine; Drug: Oxycodone

Saline

PLACEBO COMPARATOR

Continuous saline infusion until catheter removal (typically 36 hours)

Device: ReLeaf catheter; Drug: Saline; Drug: Morphine; Drug: Oxycodone

Interventions

ReLeaf catheter DEVICE

Continuous infusion rate 10ml/hr (5ml/side)

Ropivacaine; Saline

Ropivacaine DRUG

Also known as: Naropin

Ropivacaine

Saline DRUG

Saline

Morphine DRUG

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

Ropivacaine; Saline

Oxycodone DRUG

10mg every 4-6 hours

Also known as: Oxycontin, Roxicodone, Oxecta

Ropivacaine; Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vital 5, LLC: lead

Related Publications (4)

• 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.

  PMID: 16261108 BACKGROUND

• 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.

  PMID: 15220788 BACKGROUND

• 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.

  PMID: 14693613 BACKGROUND

• 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.

  PMID: 18197109 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Ropivacaine; Sodium Chloride; Morphine; Oxycodone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 18, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 22, 2016

Record last verified: 2016-01