Effects of local intraoperative epidural use of triamcinolone acetonide-soaked Gelfoam on postoperative outcomes in patients undergoing posterolateral lumbar spinal fusion surgery: a randomized, placebo-controlled, double-blind trial.

OBJECTIVE: Prior evidence has supported the use of local intraoperative epidural steroids in lumbar discectomy for improvements in postoperative pain and outcomes. However, currently there is a paucity of data regarding the efficacy of local epidural steroids in spinal fusion procedures. The present investigation aimed to evaluate the impact of local epidural administration of triamcinolone acetonide-soaked Gelfoam on postoperative pain and patient-reported outcomes in patients undergoing instrumented posterolateral lumbar spinal fusion. METHODS: In this randomized, double-blind, placebo-controlled trial, patients were randomly divided into two groups (treatment and control). Patients in the treatment group received a Gelfoam carrier soaked in 1 ml of triamcinolone acetonide (40 mg), which was placed over the nerve roots in the epidural space before the closure. Patients in the control group received a Gelfoam carrier soaked in normal saline in a similar fashion to the treatment group. Patients were followed up during their hospital stay and at 4 and 12 weeks postoperatively. The primary outcome measure was early postoperative visual analog scale (VAS) scores for pain both at rest and with movement. RESULTS: A total of 100 patients were recruited in this study and were randomly allocated to the treatment or control group. No significant difference was found in baseline demographic, clinical, and surgical characteristics between the two groups. Postoperative VAS scores for pain both at rest and with movement were comparable between the treatment and control groups. Cumulative morphine consumption, length of hospital stay, and incidence of postoperative complications such as surgical site infection were also similar between the two groups. There was no significant difference in patient-reported outcomes including VAS scores for back and leg pain as well as the Oswestry Disability Index at 4 and 12 weeks postoperatively. The proportion of patients who achieved a minimum clinically important difference for patient-reported outcomes were also similar between the two groups. CONCLUSIONS: In contrast to the existing literature on the beneficial use of local intraoperative epidural steroids in conventional lumbar discectomy, the present study did not demonstrate such significant efficacy for the use of local epidural steroids in instrumented posterolateral lumbar spinal fusion. However, there is still a lack of evidence in this regard and further high-quality clinical trials are required to evaluate the efficacy of local epidural steroids in this group of patients.

Protein Supplement and Enhanced Recovery After Posterior Spine Fusion Surgery: A Randomized, Double-blind, Placebo-controlled Trial.

STUDY DESIGN: This was a randomized, double-blind clinical trial study. OBJECTIVE: The objective of this study was to evaluate the effect of protein supplementation on vertebral fusion and enhanced recovery after posterior spine fusion (PSF) surgery. SUMMARY OF BACKGROUND DATA: Nonfusion is one of the most common complications of lumbar spine surgery. It has been shown that protein plays an important role in bone repair; however, its correlation to vertebral fusion following PSF surgery is unknown. PATIENTS AND METHODS: In this randomized, double-blind clinical trial study, the intervention group received a diet with 1.2 g of protein plus high-protein supplement (36 g whey protein), and the control group received a similar diet, except for starch as a placebo from 48 hours before to 1 month after surgery. RESULTS: The intervention group showed a significantly higher rate of vertebral fusion compared with the control group (P=0.019). Surgical site infection and pain were significantly lower in the intervention group. A significant difference was found in the wound healing rate in favor of the intervention group. The rates of decrease in serum high-sensitivity C-reactive protein levels and increase in serum levels of insulin-like growth factor 1, albumin, total protein, and alkaline phosphatase were greater in the intervention group than in the control group (P<0.001). CONCLUSIONS: Increased protein intake improves vertebral fusion and enhances recovery in patients undergoing PSF. This was the first study to investigate the effect of protein on fusion and healing factors; as a result, further clinical trials are needed to confirm the current results.

Single high-dose vitamin D3 injection and clinical outcomes in brain tumor resection: A randomized, controlled clinical trial.

BACKGROUND & AIMS: Vitamin D is known as a neuroprotective hormone with anti-inflammatory and immune-modulatory properties. We evaluated the effect of vitamin D3 injection on vitamin D status and clinical outcomes in patients with low serum levels of 25-hydroxyvitamin D [25(OH)D] undergoing craniotomy for brain tumor resection. METHODS: Patients with benign brain tumors and serum 25(OH)D levels ≤20 ng/mL were randomized to two groups with an equal number of subjects. The study group (n = 30) received intramuscular injection of 300,000 IU vitamin D3 prior to surgery. The control group (n = 30) was left without intervention, and both groups underwent routine therapies. RESULTS: On day 5 after craniotomy, the serum 25(OH)D levels increased significantly in the study group (P= <0.001). The length of ICU and hospital stay was significantly lower in the study group compared to the control group (P = 0.01 and P = 0.008, respectively). It was true when the age, tumor size, tumor type, Karnofsky Performance Scale (KPS) score, and calcium and albumin levels at baseline entered the logistic regression model (OR = 0.17 (95%CI = 0.04-0.72, P = 0.01), and OR = 0.19 (95%CI = 0.04-0.82, P = 0.02), respectively). With and without the application of logistic regression analysis, there was no significant difference in perioperative complications. CONCLUSIONS: Intramuscular injection of 300,000 IU of vitamin D3 in patients with low serum levels of 25(OH)D undergoing craniotomy, could rise safely the serum 25(OH)D level. This intervention, significantly reduced the length of ICU stay and hospitalization. REGISTERED UNDER: Clinicaltrials.gov.identifier no: NCT03248544. Date: 8/14/2017.