Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02293525
• Other study ID #: CLI-001-0201
• Status: Withdrawn
• Phase: N/A
• First received: October 27, 2014
• Last updated: January 20, 2016
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Vital 5, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Device:
• ReLeaf catheter
Continuous infusion rate 10ml/hr (5ml/side)

Drug:
• Ropivacaine

• Saline

• Morphine
Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg
• Oxycodone
10mg every 4-6 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vital 5, LLC

References & Publications (4)

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):166-72, table of contents. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Hospital Stay	Time from surgery to hospital discharge, on average 2 to 3 days	Discharge, on average 2 to 3 days	No
Other	Incisional Pain	Pain at the site of the incision at 3 months post-operative	3 months	No
Other	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	No
Other	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	No
Other	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	No
Primary	Pain (Mean VAS pain score at 24 hours post-procedure)	Mean VAS pain score at 24 hours post-procedure	24 hours	No
Secondary	Medication Use	Narcotic use from surgery through 3 months post-operative	3 months	No
Secondary	Adverse Events	Occurrence of adverse events through 3 months post-operative	3 months	Yes