aBBreViatiONS ADAS-cog-11 = Alzheimer's Disease Assessment Scale cognitive subscale; AD = Alzheimer's disease; AE = adverse event; DBS = deep brain stimulation; DBS-f = deep brain stimulation of the fornix; IPG = internal pulse generator; PD = Parkinson's disease; SAE = serious adverse event. OBJectiVe This report describes the stereotactic technique, hospitalization, and 90-day perioperative safety of bilateral deep brain stimulation (DBS) of the fornix in patients who underwent DBS for the treatment of mild, probable Alzheimer's disease (AD). methOdS The ADvance Trial is a multicenter, 12-month, double-blind, randomized, controlled feasibility study being conducted to evaluate the safety, efficacy, and tolerability of DBS of the fornix in patients with mild, probable AD. Intraoperative and perioperative data were collected prospectively. All patients underwent postoperative MRI. Stereotactic analyses were performed in a blinded fashion by a single surgeon. Adverse events (AEs) were reported to an independent clinical events committee and adjudicated to determine the relationship between the AE and the study procedure. reSultS Between June 6, 2012, and April 28, 2014, a total of 42 patients with mild, probable AD were treated with bilateral fornix DBS (mean age 68.2 ± 7.8 years; range 48.0-79.7 years; 23 men and 19 women). The mean planned target coordinates were x = 5.2 ± 1.0 mm (range 3.0-7.9 mm), y = 9.6 ± 0.9 mm (range 8.0-11.6 mm), z = -7.5 ± 1.2 mm (range -5.4 to -10.0 mm), and the mean postoperative stereotactic radial error on MRI was 1.5 ± 1.0 mm (range 0.2-4.0 mm). The mean length of hospitalization was 1.4 ± 0.8 days. Twenty-six (61.9%) patients experienced 64 AEs related to the study procedure, of which 7 were serious AEs experienced by 5 patients (11.9%). Four (9.5%) patients required return to surgery: 2 patients for explantation due to infection, 1 patient for lead repositioning, and 1 patient for chronic subdural hematoma. No patients experienced neurological deficits as a result of the study, and no deaths were reported. cONcluSiONS Accurate targeting of DBS to the fornix without direct injury to it is feasible across surgeons and treatment centers. At 90 days after surgery, bilateral fornix DBS was well tolerated by patients with mild, probable AD.Clinical trial registration no.: NCT01608061 (clinicaltrials.gov) http://thejns.org/doi/abs/10.3171/2015.6.JNS15716
Study Design: A prospective observational study with a historical reference group. Objectives: The main objectives of this study were to determine the impact of preventative multimodal analgesia (PMA) on postoperative opioid requirements and analgesic effectiveness in patients undergoing lumbar fusion surgery. Summary of Background Data: PMA addresses the multiple pathways of acute and chronic pain by interfering with peripheral and central sensitization and should provide a way to achieve safer and more effective pain management with reduced opioid medication use. Materials and Methods: This study compared postoperative opioid requirement and analgesic effect in a total of 101 patients undergoing elective, 1-level or 2-level transforaminal lumbar interbody fusion surgeries for symptomatic lumbar degenerative disk disease. The PMA patient group included 51 consecutive patients who received 1000 mg of acetaminophen, 300–900 mg of gabapentin, and 200–400 mg of celecoxib 1 hour before their index procedure. The reference group included 50 patients who received 15 mg of morphine-equivalent dose (MED) preoperatively. Multiple linear regression was used to evaluate the effect of PMA on postoperative pain and MED over 4 postoperative days, while controlling for all variables likely to influence these outcomes, including age, sex, baseline opioid use, duration of surgery, postoperative intrathecal morphine use and the administration of muscle relaxants and anticonvulsants. Results: The differences in opioid requirement and postoperative pain scores were statistically significant on all 4 postoperative days. The effect size varied from −0.54 to −0.99 (34.8%–54.2% MED reduction) for the postoperative opioid requirement and from −0.59 to −1.16 (28.9%–37.3% visual analog scale reduction) for postoperative pain indicating that these measures were reduced by about ½ to 1 SD in the PMA patient group. Conclusions: PMA is a highly effective and safe method for postoperative pain management in patients undergoing elective lumbar fusion surgeries by improving pain control and reducing opioid requirement. Level of Evidence: Level III.
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