Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

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.

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