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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Continuous infusion rate 10ml/hr (5ml/side)
Pain (Mean VAS pain score at 24 hours post-procedure)
Mean VAS pain score at 24 hours post-procedure
Time frame: 24 hours
Medication Use
Narcotic use from surgery through 3 months post-operative
Time frame: 3 months
Adverse Events
Occurrence of adverse events through 3 months post-operative
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg
10mg every 4-6 hours