Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Saline; Device: ReLeaf catheter; Drug: Morphine; Drug: Oxycodone

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine; Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)	Drug: Ropivacaine; Other Names: Naropin; Device: ReLeaf catheter; Continuous infusion rate 10ml/hr (5ml/side); 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 Names: Oxycontin, Roxicodone, Oxecta
Placebo Comparator: Saline; Continuous saline infusion until catheter removal (typically 36 hours)	Drug: Saline; Device: ReLeaf catheter; Continuous infusion rate 10ml/hr (5ml/side); 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 Names: Oxycontin, Roxicodone, Oxecta

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Time from surgery to hospital discharge, on average 2 to 3 days	Discharge, on average 2 to 3 days
Incisional Pain	Pain at the site of the incision at 3 months post-operative	3 months
Incidence of nausea and vomiting	Occurrence of nausea with or without vomiting and treatments from time of surgery through hospital discharge (which is 2-3 days on average)	Discharge, on average 2 to 3 days
Time of Foley Catheter Removal	Time foley catheter was removed following surgery but no later than hospital discharge (which is 2-3 days on average)	Discharge, on average 2 to 3 days
Time to First Ambulate	Time to walk following surgery but no later than hospital discharge (which is 2-3 days on average)	Discharge, on average 2 to 3 days

Collaborators and Investigators

• Sponsor: Vital 5, LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine; Oxycodone
• Other Study ID Numbers: CLI-001-0201