This report of a FDA-monitored clinical trial provides some encouraging news for the 20 per cent of patients who suffer increased back and leg pain after discectomy (disc removal). A new product called oxiplex gel is being investigated with good results so far.
Oxiplex gel is applied to all the soft tissues around the surgical site after the disc has been removed. A coating is placed on the nerve root, annulus fibrosus (covering around the disc), and dura (lining around the spinal cord). It works like teflon to create a mechanical barrier that keeps out pain messages. And it even reduces the amount of scar tissue called fibrosis that can develop after surgery.
In this study, two groups of patients were compared: one group received the oxiplex while the second (control) group did not. Patients in both groups had the same surgical procedure: a single level laminectomy or laminotomy and discectomy. A laminectomy involves cutting away some of the back of the vertebral bone (the lamina) in order to remove the central portion of the herniated disc. In a laminotomy, the surgeon drills a hole through the lamina to aspirate (suck out) the disc.
The results were measured based on back and leg pain before and after surgery and presence of other distressing (adverse) symptoms. Patient satisfaction and number of disability days were also compared. And each patient was examined for neurological and motor function (e.g., numbness, weakness, dizziness, headache, loss of sensation, muscle or joint pain, stiffness, muscle spasm). The last comparison made between the two groups was the number of reoperations necessary due to pain.
After analyzing all the data collected, they found that for patients with severe pain before surgery, the use of oxiplex gel made a significant difference. Those folks had less postoperative back and leg pain, fewer reoperations, and greater satisfaction with the results. There were also fewer patients in the oxiplex gel group who had adverse effects after surgery and there were fewer abnormal musculoskeletal problems as well.
From this preliminary study, it looks like this new oxiplex gel is safe and effective for relieving the postoperative pain many patients experience after discectomy. This was especially true for the more challenging patients who had severe back pain before surgery (a group likely to experience persistent pain after surgery). One of the other advantages of the oxiplex gel was the prevention of cerebrospinal fluid leaks. With the gel painted on the dura, the fluid was contained, which also prevented any postoperative headaches.