Postoperative Single-shot Epidural Fentanyl and Bupivacaine for Postoperative Analgesia After Lumbar Decompression: A Prospective, Double-blind Randomized Study.

STUDY DESIGN: Randomized clinical trial. OBJECTIVE: To evaluate the efficacy of the postoperative single-shot bolus of epidural Fentanyl and Bupivicaine in providing pain relief postlumbar decompression surgery. SUMMARY OF BACKGROUND DATA: Despite lumbar decompression's success in alleviating symptoms of sciatica, radiculopathy, and neurogenic claudication, transient back and buttock pain has been a common complaint postoperatively. Providing good postoperative pain alleviation predicts patient's quality of recovery. METHODS: We performed a randomized, double-blinded, clinical trial. Forty-five patients scheduled for lumbar decompression for a year's period who were randomly assigned to receive a postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution via an intraoperatively placed epidural catheter immediately after wound closure, before dressing application. Facial pain scale scores (from 0 to 10) were measured at three time points after surgery (fully awake at recovery room, transfer to ward, first postoperative day). Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge were also evaluated. RESULTS: Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001). In turn, they also received less on-demand oral pain medications than those in the control group (P = 0.000). The mean time to ambulation was 0.09 days in the epidural group and 0.91 days in the decompression-alone group (P = 0.000). Criteria for hospital discharge were usually met on Day 0 in the epidural and Day 1 in the control group (P = 0.000). Within the study period, only one infection was noted in the epidural group which necessitated additional lumbar spine surgery (4.3%). No adverse events or complications related to Fentanyl use were observed. CONCLUSIONS: A postoperative bolus of Fentanyl and Bupivacaine is effective in reducing early postoperative pain without the related complications of opiod administration. LEVEL OF EVIDENCE: 2.

Percutaneous posterior cervical fusion with the DTRAX Facet System for single-level radiculopathy: results in 60 patients.

OBJECT: The authors present 1-year results in 60 patients with cervical radiculopathy due to spondylosis and stenosis that was treated with a bilateral percutaneous facet implant. The implant consists of a screw and washer that distracts and immobilizes the cervical facet for root decompression and fusion. Clinical and radiological results are analyzed. METHODS: Between 2009 and 2011, 60 patients were treated with the DTRAX Facet System in a multicenter prospective single-arm study. All patients had symptomatic clinical radiculopathy, and conservative management had failed. The majority of patients had multilevel radiographically confirmed disease. Only patients with single-level radiculopathy confirmed by history, physical examination, and in some cases confirmatory nerve blocks were included. Patients were assessed preoperatively with Neck Disability Index, visual analog scale, quality of life questionnaire (Short Form-12 version 2), CT scans, MRI, and dynamic radiographs. Surgery was percutaneous posterior bilateral facet implants consisting of a screw and expandable washer and iliac crest bone aspirate. Patients underwent postoperative assessments at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year with validated outcome questionnaires. Alterations of segmental and overall cervical lordosis, foraminal dimensions, device retention and fusion criteria were assessed for up to 1 year with CT reconstructions and radiographs. Fusion criteria were defined as bridging trabecular bone between the facets, translational motion < 2 mm, and angular motion < 5°. RESULTS: All patients were followed to 1 year postoperatively. Ages in this cohort ranged from 40 to 75 years, with a mean of 53 years. Forty-two patients were treated at C5-6, 8 at C6-7, 7 at C4-5, and 3 at C3-4. Fifty-six had bilateral implants; 4 had unilateral implants due to intraoperative facet fracture (2 patients) and inability to access the facet (2 patients). The Neck Disability Index, Short Form-12 version 2, and visual analog scale scores were significantly improved at 2 weeks and remained significantly improved up to 1 year. At the treated level, 93% had intrafacet bridging trabecular bone on CT scans, translational motion was < 2 mm in 100% and angular movement was < 5° in 83% at the 1-year follow-up. There was no significant change in overall cervical lordosis. There was a 1.6° loss of segmental lordosis at the treated level at 1 year that was significant. Foraminal width, volume, and posterior disc height was significantly increased at 6 months and returned to baseline levels at 1 year. There was no significant decrease in foraminal width and height at adjacent levels. There were no reoperations or surgery- or device-related complications, including implant failure or retained hardware. CONCLUSIONS: Results indicate that the DTRAX Facet System is safe and effective for treatment of cervical radiculopathy.