An interventional study of ReLeaf catheter and Ropivacaine in Low Back Pain, sponsored by Vital 5, LLC. Withdrawn. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-01-22.
Sponsored by Vital 5, LLC · Not applicable, Interventional, and Supportive care
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
Browse Low Back Pain studies →This is the only study on the registry with Vital 5, LLC as lead sponsor.
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Exclusion Criteria:
Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)
Device: ReLeaf catheter · Drug: Ropivacaine · Drug: Morphine · Drug: Oxycodone
Continuous saline infusion until catheter removal (typically 36 hours)
Device: ReLeaf catheter · Drug: Saline · Drug: Morphine · Drug: Oxycodone
Continuous infusion rate 10ml/hr (5ml/side)
Also known as: Naropin
Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg
10mg every 4-6 hours
Also known as: Oxycontin, Roxicodone, Oxecta
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
Length of Hospital Stay
Time from surgery to hospital discharge, on average 2 to 3 days
Time frame: Discharge, on average 2 to 3 days
Incisional Pain
Pain at the site of the incision at 3 months post-operative
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Discharge, on average 2 to 3 days
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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