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Analgesic Effect of Intraoperative Intravenous S-Ketamine in Opioid-Naïve Patients After Major Lumbar Fusion Surgery Is Temporary and Not Dose-Dependent: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Brinck, ECV, Maisniemi, K, Kankare, J, Tielinen, L, Tarkkila, P, Kontinen, VK
Anesthesia and analgesia. 2021;(1):69-79
Abstract
BACKGROUND Severe pain often accompanies major spine surgery. Opioids are the cornerstone of postoperative pain management but their use can be limited by numerous side effects. Several studies claim that adjuvant treatment with intravenous (IV) ketamine reduces opioid consumption and pain after back surgery. However, the exact role of ketamine for this indication is yet to be elucidated. We compared 2 different doses of S-ketamine with placebo on postoperative analgesic consumption, pain, and adverse events in adult, opioid-naïve patients after lumbar fusion surgery. METHODS One hundred ninety-eight opioid-naïve patients undergoing lumbar spinal fusion surgery were recruited to this double-blind trial and randomly assigned into 3 study groups: Group C (placebo) received a preincisional IV bolus of saline (sodium chloride [NaCl] 0.9%) followed by an intraoperative IV infusion of NaCl 0.9%. Both groups K2 and K10 received a preincisional IV bolus of S-ketamine (0.5 mg/kg); in group K2, this was followed by an intraoperative IV infusion of S-ketamine (0.12 mg/kg/h), while in group K10, it was followed by an intraoperative IV infusion of S-ketamine (0.6 mg/kg/h). Postoperative analgesia was achieved by an IV patient-controlled analgesia (IV PCA) device delivering oxycodone. The primary end point was cumulative oxycodone consumption at 48 hours after surgery. The secondary end points included postoperative pain up to 2 years after surgery, adverse events, and level of sedation and confusion in the immediate postoperative period. RESULTS The median [interquartile range (IQR)] cumulative oxycodone consumption at 48 hours was 154.5 [120] mg for group K2, 160 [109] mg for group K10, and 178.5 [176] mg for group C. The estimated difference was -24 mg between group K2 and group C (97.5% confidence interval [CI], -73.8 to 31.5; P = .170) and -18.5 mg between group K10 and C (97.5% CI, 78.5-29.5; P = .458). There were no significant differences between groups.Postoperative pain scores were significantly lower in both ketamine treatment groups at the fourth postoperative hour but not later during the 2-year study period.The higher ketamine dose was associated with more sedation. Otherwise, differences in the occurrence of adverse events between study groups were nonsignificant. CONCLUSIONS Neither a 0.12 nor a 0.6 mg/kg/h infusion of intraoperative IV S-ketamine was superior to the placebo in reducing oxycodone consumption at 48 hours after lumbar fusion surgery in an opioid-naïve adult study population. Future studies should assess ketamine's feasibility in specific study populations who most benefit from reduced opioid consumption.
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Randomized Controlled Trial Evaluating the Use of Zoledronic Acid in Duchenne Muscular Dystrophy.
Zacharin, M, Lim, A, Gryllakis, J, Siafarikas, A, Jefferies, C, Briody, J, Heather, N, Pitkin, J, Emmanuel, J, Lee, KJ, et al
The Journal of clinical endocrinology and metabolism. 2021;(8):2328-2342
Abstract
CONTEXT Patients with glucocorticoid-dependent Duchenne muscular dystrophy (DMD) have increased fracture risk and reduced bone mineral density (BMD), often precipitating mobility loss. OBJECTIVE To investigate use of zoledronic acid (ZA) in DMD in improving BMD. METHODS Two arm, parallel, randomized controlled trial, set in pediatric hospitals across Australia and New Zealand. Sixty-two (31 per arm) boys with glucocorticoid-dependent DMD between 6 and 16 years were included. Five ZA infusions (0.025 mg/kg at months 0, and 3, and 0.05 mg/kg at months 6, 12, and 18), plus calcium and vitamin D, were compared with calcium and vitamin D alone. The main outcome measures were change in lumbar spine (LS) BMD raw and Z-score by dual energy absorptiometry x-ray (DXA) at 12 and 24 months, secondary outcomes assessing mobility, fracture incidence, bone turnover, peripheral quantitative computerized (pQCT) and pain scores. RESULTS At 12 and 24 months, mean difference in changes of LS BMD Z-score from baseline was 1.2 SD (95% CI 0.9-1.5), higher by 19.3% (14.6-24.0) and 1.4 SD (0.9-1.9), higher by 26.0% (17.4-34.5) in ZA than control arms respectively (both P < .001). Five controls developed Genant 3 vertebral fractures, 0 in the ZA arm. Mobility, pain, and bone turnover markers were similar between arms at 12 and 24 months. Trabecular BMC and vBMD pQCT at radius and tibia were greater at 12 months in the ZA cohort than control; the evidence for this difference remained at 24 months for radius but not tibia. CONCLUSION ZA improved BMD in glucocorticoid-dependent DMD boys. Although the small cohort precluded demonstrable fracture benefit, improved BMD might reduce incident vertebral fracture.
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Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.
Dehkordy, ME, Tavanaei, R, Younesi, E, Khorasanizade, S, Farsani, HA, Oraee-Yazdani, S
Clinical neurology and neurosurgery. 2020;:105983
Abstract
OBJECTIVE Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty. PATIENTS AND METHODS Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device. RESULTS VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups. CONCLUSIONS Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.
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Implementation of magnesium sulphate as an adjunct to multimodal analgesic approach for perioperative pain control in lumbar laminectomy surgery: A randomized placebo-controlled clinical trial.
Tsaousi, G, Nikopoulou, A, Pezikoglou, I, Birba, V, Grosomanidis, V
Clinical neurology and neurosurgery. 2020;:106091
Abstract
OBJECTIVE To investigate the effect of systemic intraoperative administration of magnesium sulphate when used in the context of a multimodal pain management plan on analgesics consumption and pain scores, and perioperative outcomes after lumbar laminectomy surgery. METHODS Seventy-four patients undergoing lumbar laminectomy were enrolled in this randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to receive magnesium (20 mg/kg iv given as bolus before anesthesia induction followed by 20 mg/kg/h civ until surgery completion) or saline. Hemodynamic variables and desflurane consumption were noted at predefined time-intervals intraoperatively. Primary outcome was postoperative cumulative analgesic consumption over 24 h, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24 h), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points. RESULTS Demographics, surgery duration, desflurane requirements, and recovery profile were comparable between groups. Magnesium attenuated hemodynamic response during incision and emergence from anesthesia. Postoperative analgesics consumption in morphine iv equivalents (mean difference -9.24 [95 %CI -13.31, -5.17] mg; p = 0.001) and VAS scores at all-time points of assessment were lower in magnesium group; this effect peaked at 4 h (mean difference -2.15 [95 %CI -3.21,-1.09; p = 0.001]. Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01). No notable adverse effects were recorded. CONCLUSION It occurs that magnesium infusion during lumbar laminectomy surgery potentiates perioperative analgesia and reduces analgesic requirements up to 24 h postoperatively. No profound adverse effect on either intraoperative hemodynamics or any other clinically relevant endpoints becomes evident.
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Clinical, Biochemical, and Radiological Profile of Normocalcemic Primary Hyperparathyroidism.
Palermo, A, Naciu, AM, Tabacco, G, Falcone, S, Santonati, A, Maggi, D, D'Onofrio, L, Briganti, SI, Castellitto, D, Casini, A, et al
The Journal of clinical endocrinology and metabolism. 2020;(7)
Abstract
CONTEXT The clinical and radiological aspects of normocalcemic hyperparathyroidism (NHPT) are confounded by the differing methods used to rule out secondary hyperparathyroidism and by the small sample size. OBJECTIVE To assess the clinical, biochemical, and radiological profile of NHPT compared with primary hyperparathyroidism (PHPT) and control subjects. DESIGN Multicentric cross-sectional study. SETTING Outpatient clinic. PATIENTS 47 NHPT, 41 PHPT, and 39 age- and sex-matched control subjects. MAIN OUTCOME MEASURES Calcium metabolism and bone turnover markers (BTMs). Lumbar spine, total hip, femoral neck, one-third distal radius bone mineral density (BMD). Morphometric vertebral fracture (VF) assessed by dual-energy X-ray absorptiometry. RESULTS NHPT patients had significantly higher parathyroid hormone, 25(OH)-vitamin D levels and lower calcium × phosphorus product than controls (P < .001). Compared with PHPT, the NHPT group had significantly higher 25(OH) vitamin D levels (P = .016). NHPT had BTM levels similar to controls and PHPT. NHPT, PHPT, and controls have similar lumbar spine and femoral neck BMD. NHPT and controls had a similar radial BMD, while patients with PHPT had a lower radial BMD than both patients with NHPT (P = .031) and controls (P < .05). Using the control group as the reference, after adjustment for interacting factors, there was no increase in risk of moderate-severe VF in NHPT (odds ratio [OR] 1.04, 95% confidence interval [CI] 0.25-4.55), while PHPT had an increased risk (OR 3.81,95% CI 1.15-15.12). Seventy-nine percent of NHPT and 59% of PHPT patients fulfilled the criteria for asymptomatic hyperparathyroidism. CONCLUSIONS The biochemical phenotype of NHPT is intermediate between PHPT and controls. In contrast, the bone phenotype resembles controls with normal bone turnover, no significant BMD impairment, and no increased risk of VF.
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Application of polyetheretherketone cages through minimally invasive oblique retroperitoneal approach for the treatment of lumbar polymicrobial spondylodiscitis: A STROBE-compliant retrospective study with 7 cases.
Luo, W, Zhu, Y, Zhao, ZH, Ou, YS
Medicine. 2020;(17):e18594
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Abstract
Despite the plethora of evidence in support of the use of structural osseous autograft in lumbar spondylodiscitis, attention has recently been turned to the addition of synthetic materials such as polyetheretherketone (PEEK) to restore anterior vertebral column support.From January 2015 to April 2017, 7 patients with lumbar polymicrobial spondylodiscitis were surgically treated with a minimally invasive oblique retroperitoneal approach to the infected focus. The patients underwent a standard lateral minimally invasive oblique retroperitoneal approach using direct lateral interbody fusion system. The PEEK cages were loaded with autologous bone graft. All the patients underwent posterior fixation with percutaneous pedicle screw instrumentation. Lumbar function was measured using Oswestry Disability Index, and pain was measured with visual analog scale. Fusion and subsidence were also recorded.The study included 5 female and 2 male patients. The median age was 58.9 years. The duration of follow-up was 31.8 ± 6.1 months (range: 24-47). All patients recovered from the infection without relapse within 24-month follow-up. Visual analog scale significantly declined from 7.57 ± 0.53 before surgery to 1.57 ± 0.53 at 12-month follow-up. Mean Oswestry Disability Index decreased from 72.14 ± 6.82 before surgery to 22.28 ± 2.13 after surgery. All patients had solid fusion at 2-year follow-up. Fusion occurred at 6 to 15 months (mean 9.8 months).The specific use of PEEK cages in lumbar polymicrobial spondylodiscitis suggests reliable outcome in terms of clinical and imaging outcomes in our limited cases.
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Muscle mass, assessed at diagnosis by L3-CT scan as a prognostic marker of clinical outcomes in patients with gastric cancer: A systematic review and meta-analysis.
Rinninella, E, Cintoni, M, Raoul, P, Pozzo, C, Strippoli, A, Bria, E, Tortora, G, Gasbarrini, A, Mele, MC
Clinical nutrition (Edinburgh, Scotland). 2020;(7):2045-2054
Abstract
BACKGROUND & AIMS Computed tomographic (CT) imaging at third lumbar vertebra (L3), routinely used by oncologists, represents a reliable tool to quantify muscle mass. A systematic review and meta-analysis was performed to assess the efficacy of CT scan to define muscle mass as a prognostic marker in gastric cancer (GC) patients undergoing gastrectomy and/or chemotherapy. The primary outcomes were overall survival (OS) and recurrence-free survival (RFS) and the secondary outcomes included postoperative length of hospital stay (P-LOS), total and severe complications in GC patients undergoing gastrectomy. METHODS Three electronic bibliographic databases - MEDLINE, Web of Science and Cochrane Central Register of Controlled Trials - were used to conduct a systematic literature search based on fixed inclusion and exclusion criteria, until April 2019. The adjusted and unadjusted hazard ratio (HR), odds ratio (OR) and mean difference (MD) with 95% confidence interval (CI) were used to analyse the dichotomous variables (OS, RFS, total and severe complications) and continuous variables (P-LOS). Random- and fixed effects models were used according to the heterogeneity. RESULTS A total of 5610 GC patients from 20 studies were identified. Low muscle mass at diagnosis was found in 32.7% of GC patients and was significantly associated with poorer OS (HR 2.02, 95% CI 1.71-2.38, p < 0.00001, I2 = 47%) and worse RFS (HR 1.97, 95% CI 1.71-2.26, p < 0.00001, I2 = 0%). Meta-analysis of adjusted HR from multivariable analyses confirmed the association between OS and low muscle mass (HR 1.89, 95% CI 1.68-2.12, p < 0.00001, I2 = 36%). Furthermore, low muscle mass and poorer OS were significantly associated in metastatic GC patients exclusively undergoing chemotherapy (HR 1.61, 95% CI 1.23-2.11, p < 0.0006, I2 = 18%). Moreover, preoperative low muscle mass was significantly associated with longer P-LOS (MD 1.19, 95% CI 0.68-1.71, p < 0.00001, I2 = 0%), higher risk of postoperative complications (OR 1.76, 95% CI 1.17-2.66, p = 0.007, I2 = 77%) and severe complications (OR 1.54, 95% CI 1.03-2.29, p = 0.04, I2 = 49%) in GC patients undergoing gastrectomy. CONCLUSIONS Low muscle mass, assessed by L3 CT-scan, affects almost 1/3 of GC patients at diagnosis and acts as a negative prognostic marker on many clinical outcomes. Therefore, identifying GC patients with low muscle mass at diagnosis or at follow-up visit should be recommendable. Clinical nutritionists should be part of tumor boards meetings to screen low muscle mass in order to prompt personalized nutritional support.
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No Difference in Pain After Spine Surgery with Local Wound Filtration of Morphine and Ketorolac: A Randomized Controlled Trial.
Singhatanadgige, W, Chancharoenchai, T, Honsawek, S, Kotheeranurak, V, Tanavalee, C, Limthongkul, W
Clinical orthopaedics and related research. 2020;(12):2823-2829
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Abstract
BACKGROUND Controlling postoperative pain after spinal surgery is important for rehabilitation and patient satisfaction. Wound infiltration with local anesthetics may improve postoperative pain, but true multimodal approaches for achieving analgesia after spinal surgery remain unknown. QUESTIONS/PURPOSES In this randomized, controlled, double-blind trial after lumbar interbody fusion, we asked: (1) Does multimodal analgesia reduce VAS pain scores by a clinically important amount? (2) Does this analgesic approach reduce the amount of morphine patients consume after surgery? (3) Is this approach associated with fewer opioid-related side effects after surgery? METHODS This study included 80 adult patients undergoing lumbar interbody fusion who were randomized into two groups: A control group (n = 40) who received infiltration of the surgical incision at the end of the procedure with an injection of 0.5% bupivacaine 100 mg (20 mL) and epinephrine 0.5 mg (0.5 mL), and the multimodal group (n = 40), who received wound infiltration with the same approach but with different medications: 0.5% bupivacaine 92.5 mg (18.5 mL), ketorolac 30 mg (1 mL), morphine 5 mg (0.5 mL), and epinephrine 0.5 mg (0.5 mL). There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time. All treatments were administered by one surgeon. All patients, the surgeon, and the researchers were blinded to the allocation of patients to each group. Pain at rest was recorded using the VAS. Postoperative morphine consumption (administered using a patient-controlled analgesia pump) and opiod-associated side effects including nausea/vomiting, pruritus, urinary retention, and respiratory depression were assessed; this study was analyzed according to intention-to-treat principles. No loss to follow-up or protocol deviations were noted. We considered a 2-cm change on a 10-cm scale on the VAS as the minimum clinically important difference (MCID). Differences smaller than this were considered unlikely to be important. RESULTS At no point were there between-group differences in the VAS scores that exceeded the MCID, indicating no clinically important reductions in pain associated with administering multimodal injections. The highest treatment effect was observed at 3 hours that showed only a -1.3 cm mean difference between the multimodal and the control groups (3.2 ± 1.8 versus 4.5 ± 1.9 [95% CI -1.3 to -0.3]; p < 0.001), which was below the MCID. Morphine consumption was very slightly higher in the control group than in the multimodal group (2.8 ± 2.8 versus 0.3 ± 1.0, mean difference 2.47; p < 0.001). The percentage of patients reporting opioid-related side effects was lower in the multimodal group than in the control group. The proportions of nausea and vomiting were higher in the control group (30% [12 of 40] than in the multimodal group (3% [1 of 40]; p = 0.001). All of these side effects were transient and none was severe. CONCLUSIONS Multimodal wound infiltration with an NSAID and morphine did not yield any clinically important reduction in pain or opioid consumption. Since no substantial benefit of adding these drugs to a patient's aftercare regimen was achieved, and considering the potential risks of administering opioids and NSAIDs (such as, polypharmacy in older patients, serious adverse effects of NSAIDs), we recommend against routine use of this approach in clinical practice. LEVEL OF EVIDENCE Level I, therapeutic study.
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Safety and Efficacy of Hydrogen Peroxide in Controlling Blood Loss and Surgical Site Infection After Multisegmental Lumbar Spine Surgery: A Retrospective, Case-Controlled Study.
Chen, H, Yang, JS, Zou, P, Zhao, YT, Liu, TJ, Tian, Y, Ding, KY, Liu, P, Zhang, JN, Hao, DJ
World neurosurgery. 2020;:e303-e307
Abstract
OBJECTIVE To explore the safety and efficacy of hydrogen peroxide H2O2 in controlling blood loss and surgical site infection (SSI) after multisegmental lumbar spine surgery. METHODS A total of 2626 patients who had undergone multisegmental lumbar spinal surgery from January 2015 to January 2018 were included in the present study. Stratified by the use of H2O2 irrigation, they were divided into 2 groups: the control group (n = 1345) and the experimental group (n = 1281). The demographic parameters, laboratory examination results, and surgery-related information (e.g., operative time, number of operated levels, intraoperative blood loss, postoperative drainage, postoperative SSI, extubation time), and perioperative complications were recorded. RESULTS No significant differences were seen regarding the demographic parameters, laboratory examination results, comorbidities, and surgery-related information. The extubation time and postoperative drainage collection were lower in the experimental group (3.6 ± 0.5 vs. 4.1 ± 0.6 days, P = 0.402; 251.8 ± 67.5 vs. 291.8 ± 71.3 mL, P = 0.013). In the control group, the rate of SSI was 2.4% (32 of 1345) and included 17 superficial wound infections and 15 deep wound infections. In the experimental group, the SSI rate was 1.4% (18 of 1281; 15 with a superficial wound infection and 3 with a deep wound infection). Staphylococcus aureus was the most common organism, especially in the experimental group (66.7% vs. 50%). No statistically significant difference was found between the 2 groups in the perioperative complications, including hematencephalon, deep vein thrombosis, pulmonary embolism, and myocardial infarction (P > 0.05). Pneumocephalus was not observed in either group. CONCLUSION The application of H2O2 in posterior lumbar interbody fusion can reduce the blood loss and incidence of SSI after surgery and was quite beneficial for controlling the increasing number of vancomycin-resistant bacteria.
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Vitamin D Receptor gene polymorphisms and plasma levels are associated with lumbar disc degeneration.
Yang, Q, Liu, Y, Guan, Y, Zhan, X, Xiao, Z, Jiang, H, Wei, Q
Scientific reports. 2019;(1):7829
Abstract
The purpose of this study was to investigate the association of Vitamin D Receptor (VDR) gene polymorphisms and VDR levels with lumbar disc degeneration (LDD). TaqMan SNP Genotyping Assay was utilized to probe VDR gene polymorphisms including the FokI (rs2228570), ApaI (rs7975232) and TaqI (rs731236) in 454 patients with LDD and 485 controls. Enzyme-Linked Immunosorbent Assay (ELISA) was used to detect plasma VDR levels. The patients with LDD were divided into three subgroups (subgroup 1: lumbar disc herniation; subgroup 2: lumbar spinal stenosis; subgroup 3: lumbar spondylolisthesis) to further probe the association of plasma VDR levels and VDR gene polymorphisms and LDD. Moreover, immunohistochemistry (IHC) was implemented to evaluate VDR expression in lumbar degenerated disc and normal disc. Allele and genotype frequency of TaqI (rs731236) were significantly different in patients with LDD and controls (all P < 0.05). For TaqI polymorphism, the frequencies of T allele were significantly higher in the LDD patients compared with controls (OR = 1.319; 95%CI 1.091 to 1.595; P = 0.004, adjusted (OR = 1.319; 95%CI 1.091 to 1.595; P = 0.004, adjusted OR = 1.383; 95%CI 1.135 to 1.684; P = 0.016). Furthermore, the allele distribution showed a higher frequency of the T allele in the patients with lumbar disc herniation in subgroup 1 (OR = 1.384; 95% CI 1.105 to 1.732; P = 0.004, adjusted OR = 1.319; 95%CI 1.091 to 1.595; P = 0.016). Plasma VDR levels and VDR expression were significantly lower in patients with LDD compared with controls (all P < 0.05). Moreover, the TT genotype of TaqI polymorphism was significantly associated with lower plasma VDR levels in patients with LDD (P = 0.002). TaqI (rs731236) polymorphism was associated with a predisposition to LDD. Plasma VDR and VDR expression levels may be the marker for the occurrence and development of LDD.