Clinical trial NCT02293525: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Vital 5, LLC
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain (Mean VAS pain score at 24 hours post-procedure)
timeFrame: 24 hours
Secondary outcomes:
measure: Medication Use
timeFrame: 3 months
measure: Adverse Events
timeFrame: 3 months
Other outcomes:
measure: Length of Hospital Stay
timeFrame: Discharge, on average 2 to 3 days
measure: Incisional Pain
timeFrame: 3 months
measure: Incidence of nausea and vomiting
timeFrame: Discharge, on average 2 to 3 days
measure: Time of Foley Catheter Removal
timeFrame: Discharge, on average 2 to 3 days
measure: Time to First Ambulate
timeFrame: Discharge, on average 2 to 3 days
Locations:
Study officials:
References:
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.
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.
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.
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.