Post-operative pain following standard lumbar discectomy can be a significant source of morbidity. We performed a
prospective, randomized, blinded, parallel group clinical study of 352 patients (Oxiplex treated, N = 177 and surgery
only, N = 175) to assess the safety and reduction of neurological sequelae using Oxiplex intraoperative surgical gel
(FzioMed, San Luis Obispo, CA) to protect the nerve roots of patients undergoing their first single level laminotomy,
laminectomy, or discectomy at L4-L5 or L5-S1.
Patients were randomly selected to receive surgery only or surgery plus Oxiplex placed on and around the nerve root
prior to wound closure. The effectiveness of Oxiplex for the reduction of pain and associated symptoms following single
level lumbar discectomy was assessed following surgery using 1) quality of life measure (Lumbar Spine Outcomes
Questionnaire (LSOQ), BenDebba et. al., Spine J. 7:118-132), (at baseline (preop), 1, 3, and 6 months, and 2) postop
clinical evaluations at 1 and 6 months.
The demographics, surgical procedures, baseline LSOQ scores and baseline clinical evaluations were well balanced
between the Oxiplex (N=177) and surgery-only (N=175) groups. There were no cases of CSF leaks associated with the
Oxiplex treated group. There were no clinically significant differences in laboratory values or vital signs between groups.
Subjects treated with Oxiplex were consistently shown to experience greater reductions in back pain and leg pain at
6 months compared to controls, especially in the challenging group with substantial back pain at baseline (statistically
significant reduction of back pain [P=0.0193] and leg pain [P=0.0123] in the Oxiplex group compared to the control
group). More subjects in the Oxiplex group were satisfied with the outcome of their surgical treatment than subjects in
the control group (P=0.0456). Subjects in the Oxiplex group had less hypoaesthesias, paraesthesias, and sensory loss
compared to controls. Subjects in the Oxiplex group had fewer reoperations during the 6-month follow-up than subjects
in the control group (1 vs. 6).
The results of this study demonstrate that coating the dura, nerve root and laminotomy site with Oxiplex following lumbar
spine surgery is associated with a greater improvement in neurological function and less post-operative pain compared
to patients undergoing surgery alone. Taken together, these data demonstrate a consistent, clinically significant
improvement in outcome with the use of Oxiplex gel in lumbar spine surgery.