RESUMO
Background: The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation's clinical effectiveness with broader application outside of strict trial inclusion criteria. Methods: Prospective, single arm, open label effectiveness trial of 48 patients from community spine and pain practices treated with BVN ablation. Inclusion criteria required more than 6 months of CLBP and type 1 or 2 Modic changes on MRI to be enrolled. Patients were followed post procedure for 12 months using ODI, VAS, EQ-5D-5L and SF-36 patient reported outcome metrics.Results: 47 patients successfully received BVN ablation and 45 patients completed 12 months of follow up. Mean reduction in ODI at 12 months was 32.31 +/- 14.07 (p<0.001) with 88.89% (40/45) patients reporting a ≥15 point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31+/-2.51 at 12 months (p<0.001) and more than 69% reported a 50% reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved 26.27+/-17.19 and 0.22+/-0.15 (each p<0.001). Conclusions: This data supports the clinical effectiveness of BVN ablation in the community practice setting, with similar 12 month improvements in patient reported outcomes as seen in previously published randomized control trials.
RESUMO
BACKGROUND AND OBJECTIVES: The volume of epidural local anesthetic required to achieve a particular dermatomal sensory level varies significantly between patients. Studies have demonstrated random cephalad or caudad migration and direction of the epidural catheter. However, no studies have investigated the relationship between catheter direction and total volume of local anesthetic. METHODS: The study was approved by the Institutional Review Board for the Protection of Human Subjects. After obtaining informed consent, 28 patients (13 men, 15 women) scheduled for elective total knee or hip replacements were enrolled. The epidural catheter was inserted to a depth of 3 cm at L2-3 using a standard 18-gauge Tuohy needle with bevel directed either cephalad or caudad. After test dose, incremental volumes of 0.75% bupivacaine were injected to achieve a sensory anesthetic level of T6, and the total volume of drug was recorded. Immediately after surgery, 1 ml of omnipaque dye was injected through the catheter for x-ray determination of catheter-tip position. Statistical analysis used the Student's t-test and the Wilcoxon's rank sum test. RESULTS: Ages varied from 47 to 79 years (mean age, 66.5 +/- 8.51 years). Weight ranged from 51 to 125 kg (mean weight, 81.7 +/- 14.1 kg). Height ranged from 143 to 188 cm (mean height, 164.2 +/- 10.6 cm). All patients had good surgical anesthesia. Statistically significant differences (p < .001) were seen between average volumes necessary to achieve a T6 sensory level for catheters in the caudad direction (19.2 ml, n = 9) and in the cephalad direction (13.7 ml, n = 19). No statistical correlations could be demonstrated between total dose of local anesthetic and age, sex, weight, or height. CONCLUSIONS: The authors conclude that epidural catheter direction influences the total dose of local anesthetic required to achieve a specific sensory level in epidural anesthesia.
