Immune response and cytokine profiles in post-laminectomy pain syndrome: comparative analysis after treatment with intrathecal opioids, oral opioids, and non-opioid therapies.

INTRODUCTION: This study explores the interaction between cytokines, cell-mediated immunity (T cells, B cells, and NK cells), and prolonged morphine administration in chronic neuropathic pain patients without cancer-related issues. Despite evidence of opioid immunomodulation, few studies have compared these interactions. METHODS: In a cross-sectional and comparative study, 50 patients with chronic low back radicular pain ("Failed Back Surgery Syndrome") were categorized into intrathecal morphine infusion (IT group, n = 18), oral morphine (PO group, n = 17), and non-opioid treatment (NO group, n = 15). Various parameters, including plasma and cerebrospinal fluid (CSF) cytokine concentrations, lymphocyte immunophenotyping, opioid escalation indices, cumulative morphine dose, and treatment duration, were assessed. RESULTS: CSF IL-8 and IL-1ß concentrations exceeded plasma levels in all patients. No differences in T, B, and NK lymphocyte numbers were observed between morphine-treated and non-treated patients. Higher plasma IL-5 and GM-CSF concentrations were noted in IT and PO groups compared to NO. CSF IFNγ concentrations were higher in PO and NO than IT. Positive correlations included CD4 concentrations with opioid escalation indices, and negative correlations involved NK cell concentrations, CSF TNFα concentrations, and opioid escalation indices. Positive correlations were identified between certain cytokines and pain intensity in IT patients, and between NK cells and cumulative morphine dose. Negative correlations were observed between CSF IL-5 concentrations and pain intensity in IT and PO, and between opioid escalation indices and CSF cytokine concentrations in PO and IT. CONCLUSION: Associations between cytokines, cellular immunity, and prolonged morphine treatment, administered orally and intrathecally were identified.

Metformin attenuates post-epidural fibrosis by inhibiting the TGF-ß1/Smad3 and HMGB1/TLR4 signaling pathways.

Excessive post-epidural fibrosis is a common cause of recurrent back pain after spinal surgery. Though various treatment methods have been conducted, the safe and effective drug for alleviating post-epidural fibrosis remains largely unknown. Metformin, a medicine used in the treatment of type 2 diabetes, has been noted to relieve fibrosis in various organs. In the present study, we aimed to explore the roles and mechanisms of metformin in scar formation in a mouse model of laminectomy. Post-epidural fibrosis developed in a mouse model of laminectomy by spinous process and the T12-L2 vertebral plate with a rongeur. With the administration of metformin, post-epidural fibrosis was reduced, accompanied with decreased collagen and fibronectin in the scar tissues. Mechanistically, metformin decreased fibronectin and collagen deposition in fibroblast cells, and this effect was dependent on the HMGB1/TLR4 and TGF-ß1/Smad3 signalling pathways. In addition, metformin influenced the metabolomics of the fibroblast cells. Taken together, our study suggests that metformin may be a potential option to mitigate epidural fibrosis after laminectomy.

Celecoxib-Loaded Electrospun Fibrous Antiadhesion Membranes Reduce COX-2/PGE2 Induced Inflammation and Epidural Fibrosis in a Rat Failed Back Surgery Syndrome Model.

To date, failed back surgery syndrome (FBSS) remains a therapy-refractory clinical condition after spinal surgery. The antiadhesion membrane is applied to prevent FBSS by isolating fibrosis; however, the inflammation stimulated by the foreign body and surgical trauma needs to be further resolved simultaneously. Therefore, we developed new electrospun polycaprolactone (PCL) fibrous membranes loaded with celecoxib (CEL) to prevent fibrosis and inflammation associated with FBSS. The CEL-loaded PCL fibers were randomly distributed, and the drug was released over two weeks. Fluorescence micrographs revealed that the fibroblasts proliferated less on the PCL-CEL fibrous membranes than in the PCL group and the blank control. In the rat laminectomy model after 4 weeks, magnetic resonance imaging of epidural fibrosis was least in the PCL-CEL group. Expression of COX-2 and PGE2 was lower in the PCL-CEL group. It concluded that the CEL-loaded PCL membrane could reduce fibrosis and inflammation in a rat model of FBSS via COX-2/PGE2 signaling pathways.

High-Dose Spinal Cord Stimulation Reduces Long-Term Pain Medication Use in Patients With Failed Back Surgery Syndrome Who Obtained at Least 50% Pain Intensity and Medication Reduction During a Trial Period: A Registry-Based Cohort Study.

OBJECTIVES: High-dose spinal cord stimulation (HD-SCS) revealed positive results for obtaining pain relief in patients with failed back surgery syndrome (FBSS). However, it is less clear whether HD-SCS also is able to reduce pain medication use. The aim of this registry-based cohort study is to explore the impact of HD-SCS on pain medication use in FBSS patients. MATERIALS AND METHODS: Data from the Discover registry was used in which the effectiveness of HD-SCS was explored in neurostimulation-naïve FBSS patients as well as in rescue patients. All neurostimulation-naïve FBSS patients positively responded to a four-week SCS trial period in which at least 50% pain relief and 50% medication reduction were obtained. Medication use was measured with the Medication Quantification Scale III (MQS) in 259 patients at baseline and at 1, 3, and 12 months of HD-SCS. Additionally, defined daily doses (DDD) and morphine milligram equivalents (MME) were calculated as well. RESULTS: One hundred thirty patients reached the visit at 12 months. In neurostimulation-naïve patients, a statistically significant decrease in MQS (χ2 = 62.92, p < 0.001), DDD (χ2 = 11.47, p = 0.009), and MME (χ2 = 21.55, p < 0.001) was found. In rescue patients, no statistically significant improvements were found. In both patient groups, statistically significant reductions in the proportion of patients on high-risk MME doses ≥90 were found over time. At the intraindividual level, positive correlations were found between MSQ scores and pain intensity for back (r = 0.56, r = 0.31, p < 0.001) and leg pain (r = 0.61, r = 0.22, p < 0.001) in neurostimulation-naïve and rescue patients, respectively. CONCLUSIONS: Registry data on HD-SCS in FBSS patients revealed a statistically significant and sustained decrease in pain medication use, not only on opioids, but also on anti-neuropathic agents in neurostimulation-naïve patients, who positively responded to an SCS trial period with at least 50% pain relief and 50% pain medication decrease, but not in rescue patients.

Higher Preimplantation Opioid Doses Associated With Long-Term Spinal Cord Stimulation Failure in 211 Patients With Failed Back Surgery Syndrome.

OBJECTIVE: Spinal cord stimulation (SCS) is an effective treatment in failed back surgery syndrome (FBSS). We studied the effect of preimplantation opioid use on SCS outcome and the effect of SCS on opioid use during a two-year follow-up period. MATERIALS AND METHODS: The study cohort included 211 consecutive FBSS patients who underwent an SCS trial from January 1997 to March 2014. Participants were divided into groups, which were as follows: 1) SCS trial only (n = 47), 2) successful SCS (implanted and in use throughout the two-year follow-up period, n = 131), and 3) unsuccessful SCS (implanted but later explanted or revised due to inadequate pain relief, n = 29). Patients who underwent explantation for other reasons (n = 4) were excluded. Opioid purchase data from January 1995 to March 2016 were retrieved from national registries. RESULTS: Higher preimplantation opioid doses associated with unsuccessful SCS (ROC: AUC = 0.66, p = 0.009), with 35 morphine milligram equivalents (MME)/day as the optimal cutoff value. All opioids were discontinued in 23% of patients with successful SCS, but in none of the patients with unsuccessful SCS (p = 0.004). Strong opioids were discontinued in 39% of patients with successful SCS, but in none of the patients with unsuccessful SCS (p = 0.04). Mean opioid dose escalated from 18 ± 4 MME/day to 36 ± 6 MME/day with successful SCS and from 22 ± 8 MME/day to 82 ± 21 MME/day with unsuccessful SCS (p < 0.001). CONCLUSIONS: Higher preimplantation opioid doses were associated with SCS failure, suggesting the need for opioid tapering before implantation. With continuous SCS therapy and no explantation or revision due to inadequate pain relief, 39% of FBSS patients discontinued strong opioids, and 23% discontinued all opioids. This indicates that SCS should be considered before detrimental dose escalation.

Efficacy, Effectiveness, Safety, and Cost-effectiveness of Epidural Adhesiolysis for Treating Failed Back Surgery Syndrome. A Systematic Review.

BACKGROUND: Failed back surgery syndrome (FBSS) has a profound impact on patients' quality of life and represents a major clinical challenge and a significant economic burden for society. Adhesiolysis is used as a treatment to eliminate perineural/epidural adhesions in patients with chronic pain attributed to FBSS. OBJECTIVE: To evaluate the efficacy, effectiveness, safety, and cost-effectiveness of epidural adhesiolysis compared with other procedures for treating FBSS. METHOD: A systematic review was conducted. The electronic databases Medline/PreMedline, EMBASE, Cochrane Library Plus, Centre for Reviews and Dissemination databases, SCOPUS, Science Citation Index, and PEDRO were consulted through April 2017. Predefined criteria were used to determine inclusion of the studies and to assess their methodological quality. RESULTS: Ten reports were included. No randomized controlled trials (RCTs) on efficacy or cost-effectiveness were found. Three reports (corresponding to two RCTs, N = 212) suggested that adhesiolysis was effective, especially for pain and disability. However, both studies presented serious methodological flaws. In addition to RCTs, seven observational studies with high risk of bias reported data on effectiveness and safety. Fifty-eight adverse events were reported among 130 patients undergoing endoscopic adhesiolysis, and 19 among the 110 undergoing percutaneous adhesiolysis. CONCLUSIONS: The evidence on the efficacy and cost-effectiveness of adhesiolysis for treating FBSS is nonexistent, whereas evidence on its effectiveness and safety is insufficient. Incorporating data from observational studies did not improve the quality of the evidence on effectiveness.

Dextrose injections for failed back surgery syndrome: a consecutive case series.

PURPOSE: Patients with chronic low back pain, who do not respond to conservative treatment methods, generally undergo surgical revision operations, and sometimes an undesirable condition called failed back surgery syndrome (FBSS) may be inevitable. Hereby, dextrose is one of the regenerative methods that has gained popularity in the treatment of many musculoskeletal problems, and we aimed to present and evaluate the outcomes of 5% dextrose for the treatment of FBSS. METHODS: It has been designed as a consecutive case series. A total of 79 patients with FBSS, who had minimum 6 months of symptoms and did not respond to 3 months of conservative methods between May 2014 and March 2016, participated in the study. Prolotherapy injections were applied in posterior and lateral approaches. Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) were used for the pre- and post-treatment evaluations. Patient satisfaction was assessed with using a 5-point Likert scale by phone contacting. RESULTS: There was statistically significant difference between repeated VAS and ODI measurements. CONCLUSIONS: These results may be the first step giving a lead to an undiscovered field. This treatment method should be kept in mind for FBSS patients before giving a decision of revision surgery. These slides can be retrieved under Electronic Supplementary Material.

A Randomized, Multicenter, Double-Blind, Parallel Pilot Study Assessing the Effect of Mechanical Adhesiolysis vs Adhesiolysis with Corticosteroid and Hyaluronidase Administration into the Epidural Space During Epiduroscopy.

OBJECTIVE: Epiduroscopy is a proven method of diagnosis and treatment for chronic radicular pain after spinal surgery, which is known as failed back surgery syndrome (FBSS). The aim of the study was to compare the efficacy of drugs (the enzyme hyaluronidase and corticosteroid DEPO-Medrol) administrated into the epidural space during epiduroscopy, performed within the ventral and ventro-lateral epidural space with a focus on releasing foraminal adhesions. METHODS: Forty-eight patients with diagnosed FBBS were randomized into two groups before epiduroscopy. Group A received the standard treatment-mechanical lysis of fibrotic tissue in the epidural space. Group B received hyaluronidase and corticosteroid methylprednisolone acetate during the procedure. Subjects were followed for six and 12 months via scheduled double-blinded examinations by pain physicians. Leg and back pain intensity was assessed by an 11-point numerical rating scale, and patients' functional disability was assessed by the Oswestry Disability Index (ODI). RESULTS: Study subjects showed a significant decrease in ODI score in both groups (P < 0.05). Significantly lower pain scores for leg pain (P < 0.05) and back pain (P < 0.05) were also recorded after the six-month follow-up. However, the one-year follow-up showed a return to the baseline ODI values of most monitored pain scores in both groups (P > 0.05). Improvement was only noted on the NRS for back pain at one-year follow-up (P < 0.05). CONCLUSIONS: A significant improvement of leg and back pain was found in both groups after six months. ODI was significantly improved only in group B in both the six- and 12-month intervals. Back pain at one-year follow-up was only improved in group B.

Intrathecal Trialing of Continuous Infusion Combination Therapy With Hydromorphone and Bupivacaine in Failed Back Surgery Patients.

OBJECTIVES: Intrathecal (IT) trial is a prognostic interventional pain management procedure employed to determine the potential success of treating intractable pain with an implantable infusion device system. There is a dearth of data regarding trials with continuous infusion of combination therapy (e.g. opioid combined with local anesthetic). The objective of the this study was to determine the overall outcomes of continuous infusion IT trials and factors influencing long-term success of IT therapy in patients with chronic intractable pain post-laminectomy. MATERIALS AND METHODS: This is a retrospective analysis of all patients with lumbar failed back surgery syndrome (FBSS) who were trialed with a combination of hydromorphone and bupivacaine with a temporary externalized IT catheter from March 2007 to June 2014. RESULTS: From a cohort of 62 patients fulfilling the inclusion criteria, 54 (87.10%) patients had successful IT trials. No significant differences were found between successful and failed trial patients with regards to age, sex, pre-trial pain numeric rating scale scores, pre-trial morphine equivalent daily dose, or trial dosages. Significant positive correlations were found between pretrial oral opioid intake and end of trial hydromorphone dose and hydromorphone dose escalation at 12 months and 24 months. CONCLUSIONS: Patients with refractory low back pain due to FBSS who underwent successful combination IT trial with hydromorphone and bupivacaine infused through a temporary IT catheter had significantly improved pain intensity scores following permanent implant. Higher pre-trial MEDD was correlated with higher trial and post-implant opioid doses and higher rates of opioid dose escalation post-implant.

Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.

BACKGROUND: Intrathecal (IT) pumps have become a valuable tool in managing intractable non-cancer pain. The purpose of this study was to evaluate the efficacy of using a rigorous treatment algorithm for trialing and implanting IT pumps with hydromorphone and bupivacaine in managing a more homogeneous population of post-laminectomy syndrome or failed back surgery syndrome (FBSS) patients. METHODS: This is a retrospective analysis of FBSS patients with chronic intractable back pain implanted with IT pumps delivering hydromorphone and bupivacaine. RESULTS: A cohort of 57 (26 males, 31 females) consecutively implanted FBSS patients was analyzed. The average age at implant was 65.4 years. Average pain scores were 8.4 ± 0.2 (pre-implant), 4.9 ± 0.4 (6 months), 5.2 ± 0.5 (12 months), and 4.3 ± 0.5 (24 months). Average oral opioid doses in morphine equivalents were 56 ± 10 mg/day (pre-implant), 12.0 ± 3.5 mg/day (12 months), 15 ± 6 mg/day (24 months). Average IT hydromorphone doses were 79 ± 6.8 mcg/day (at implant), 184 ± 22 mcg/day (6 months), 329 ± 48 mcg/day (12 months), and 487 ± 80 mcg (24 months). IT hydromorphone dose escalation from baseline was 133% (6 months vs baseline), 78% (12 months vs 6 months), and 48% from 12 months to 24 months. Average IT bupivacaine doses were 5.8 ± 0.3 mg/day (implant), 9.5 ± 0.6 mg/day (6 months), 12.2 ± 0.7 mg/day (12 months), and 12.6 ± 0.9 mg/day (24 months). CONCLUSION: IT hydromorphone and bupivacaine are effective in treating chronic pain of FBSS, as demonstrated by the reduction of pain intensity and oral opioid consumption. However, an IT dose escalation phenomenon was observed, although at a reduced rate compared with what had been previously reported in the literature. It is possible that the local anesthetic combination delivered via a patient-activaed bolus device is an important factor. Despite demonstrating effectiveness, the clinical utility of myPTM-optimized IT therapy remains limited by a lack of prospective, placebo-controlled trials and comparative effectiveness research.

Preventive Analgesia with Pregabalin in Neuropathic Pain from "Failed Back Surgery Syndrome": Assessment of Sleep Quality and Disability.

OBJECTIVE: Pregabalin group (PGB) is an antiepileptic used to treat neuropathic pain. We evaluated analgesic efficacy and safety for postoperative/chronic pain, disability, and sleep quality in patients who underwent spine surgery administered with PGB, or not, during the presurgical and postsurgical periods. DESIGN: Retrospective cohort study of 60 patients (two groups with 30 patients) with full information on 50 (29 with PGB and 21 without PGB). Ten patients were dismissed as information was lacking. The PGB group (P) (29 patients) received 75 mg/12 hours before surgery, 150 mg 10 hours after surgery, and 150 mg/12 hours 3 days after surgery. The control group (C; 21 patients) took no PGB. METHODS: Neuropathic pain was assessed before surgery, and 2 and 6 months later using visual analog scales (VAS), DN4, disability (Oswestry), and sleep quality. No serious adverse events occurred with PGB. RESULTS: The median VAS pain score at rest was lower in the PGB group at 2 months postsurgery (1 vs 2, P = 0.032), as was the median DN4 score (0 vs 3, P = 0.032) and the median Oswestry disability index (ODI: 12 vs 18, P = 0.001). At 6 months postsurgery, pain scores were also lower in the PGB group for VAS (0 vs 4, P = 0.001), DN4 score (0 vs 4, P = 0.001) and the ODI (10 vs 24, P = 0.001). Improvement in the functionality and sleep quality of the PGB group was noteworthy (P = 0.018). CONCLUSIONS: PGB has analgesic/antihyperalgesic effects on postoperative neuropathic pain after surgery for lumbar disc hernia. Our findings show that this benefit increases with time.

Analgesic therapy for major spine surgery.

Pain following spine surgery is often difficult to control and can persist. Reduction of this pain requires a multidisciplinary approach that depends on contributions of both surgeons and anesthesiologists. The spine surgeon's role involves limiting manipulation of structures contributing to pain sensation in the spine, which requires an in-depth understanding of the specific anatomic etiologies of pain originating along the spinal axis. Anesthesiologists, on the other hand, must focus on preemptive, multimodal analgesic treatment regimens. In this review, we first discuss anatomic sources of pain within the spine, before delving into a specific literature-supported pain management protocol intended for use with spinal surgery.

What types of degenerative lumbar pathologies respond to nerve root injection? A retrospective review of six hundred and forty one cases.

PURPOSE: Peri-radicular injection is a widely used procedure for treating lumbar radicular pain, but it remains unclear what types of lumbar pathologies respond well to this treatment. We aimed to investigate the efficacy of peri-radicular injection for degenerative lumbar disorders and to determine what types of pathologies respond well to this treatment. METHODS: We reviewed the records of 641 consecutive patients who underwent peri-radicular injection for degenerative lumbar pathologies with mean follow-up of 23.4 months. The pathologies included herniated disc in 286 patients, spinal stenosis in 141, degenerative spondylolisthesis in 136, failed back surgery in 24, isthmic spondylolisthesis in 22, degenerative scoliosis in 18, and foraminal stenosis in 14. Outcome measure was whether or not surgery is avoided by using peri-radicular injection. The rate of obviating surgery was determined in each pathology. RESULTS: Peri-radicular injection obviated surgeries in 331 patients (51.7%). There were no complications related to the procedure, including neurological deterioration, infection, and haematoma. The rate of obviating surgery was 42.0% in disc herniation, 52.9% in degenerative spondylolisthesis, 67.4% in spinal stenosis, 54.5% in isthmic spondylolisthesis, 57.1% in foraminal stenosis, 61.1% in degenerative scoliosis and 54.1% in failed back surgery. Poor outcomes were observed in herniated disc with spinal stenosis (17.9% success), foraminal disc herniation (33.3%), recurrent disc herniation (18.2%) and failed back surgery with instability (33.3%). CONCLUSIONS: This study demonstrated that 51.7% of patients with degenerative lumbar pathologies were successfully treated by peri-radicular injection. Efficacy was limited in cases of herniated disc with spinal stenosis, foraminal disc herniation, recurrent disc herniation and failed back surgery with instability.

Acute rhabdomyolysis in a patient with long-term exposure to intrathecal ziconotide: a case report.

INTRODUCTION: Ziconotide is an intrathecally administered nonopioid analgesic for the treatment of severe chronic pain. Previous reports have noted rhabdomyolysis in patients receiving ziconotide during the initial single-shot trial or due to concurrent medical problems. We present a case of an acute rhabdomyolysis following an intrathecal bolus injection of ziconotide on a patient who had long-term exposure to the drug. CASE REPORT: The patient suffered from chronic neuropathic pain with diagnosis of failed back surgery syndrome and received intrathecal ziconotide for 2 years. Moderate side effects resulting from dose escalation led to a discontinuation of the drug. The pump medication was changed to morphine, which failed to provide adequate analgesia even with dose titration. A single intrathecal bolus of ziconotide, as an adjunctive therapy, resulted in good pain control. Two months later, the patient received a second ziconotide injection. Sixteen hours after the injection, she presented to local emergency center with nausea, vomiting, diarrhea, and myalgia. She had significantly increased CK levels and was admitted for intravenous hydration and close observation. Her serum CK level peaked at 4940 IU/L. The patient was discharged on hospital day 3 with a CK level of 808 IU/L. Her symptoms resolved without renal impairment. DISCUSSION: The clinical scenario described is a case of acute rhabdomyolysis from an intrathecal bolus injection of ziconotide in a patient with prior long-term exposure to the drug. The decrease in CK levels coincided well with the average half-life of ziconotide; however, the rhabdomyolysis may have been potentiated by hypokalemia.

Epidural adhesiolysis: an evidence-based review.

First described over 25 years ago, epidural lysis of adhesions (LOA) involves the mechanical dissolution of epidural scar tissue, which may directly alleviate pain and facilitate the spread of analgesic substances to area(s) of pain generation. Although it most commonly performed for lumbar failed back surgery syndrome, there is a growing body of evidence that suggests it may be effective for spinal stenosis and radicular pain stemming from a herniated disc. There is weak positive evidence that LOA is more effective than conventional caudal epidural steroid injections for failed back surgery syndrome and spinal stenosis, and that LOA is more effective than sham adhesiolysis and conservative management for lumbosacral radiculopathy. For cervical disc herniation and spinal stenosis, there is only anecdotal evidence suggesting effectiveness and safety. Factors that may contribute to the enhanced efficacy compared to traditional epidural steroid administration include the high volume administered, the use of hypertonic saline, and to a lesser extent the use of hyaluronidase and a navigable catheter to mechanically disrupt scar tissue and guide medication administration. Although LOA is widely considered a safe intervention, the complication rates are higher than for conventional epidural steroid injection.

Gabapentin versus naproxen in the management of failed back surgery syndrome; a randomized controlled trial.

Gabapentin is an analogue of the gamma amino butyric acid (GABA), which regulates the conductance of calcium channels. In this study, we compared the efficacy of gabapentin the one of naproxen in the treatment of failed laminectomy syndrome. In this controlled trial, patients who had had elective lumbar discectomy or spinal fusion surgery more than one year ago, and complaining about leg and back pain in spite of different medical therapy were randomly assigned to receive naproxen (control group) or gabapentin. Gabapentin was started at a daily dose of 300 mg. This dose was increased by 300 mg at the end of each week up to a maximum dose of 1800 mg. Naproxen, which was administered at an initial daily dose of 250 mg, was increased similarly to the maximum 1500 mg. Patients were then followed up for the next 6 consecutive months. Back and leg pains were compared between the two groups at 9 consecutive time points, namely 0, 2, 4, 6, 8, 12, 16, 20 and 32 weeks after starting the treatment. The Visual Analog Scale (VAS) score of the back pain was significantly reduced when a 600 mg daily dose of gabapentin was reached (P < 0.001). At a dose of 1800 mg, the decrease in back pain amounted 20.5%. Naproxen-treated patients did not show significant improvement in back pain. Leg pain as similarly assessed by a VAS significantly decreased when a 1200 mg dose of gabapentin was attained (P < 0.008). At 1800 mg, the reduction in VAS was 39.2%. Naproxen-treated patients had a 7.7% pain reduction at 6th week, when using the maximum daily dose of 1500 mg (P < 0.04), but the pain increased thereafter. We conclude that Gabapentin, at a maximum daily dose of 1800 mg, is significantly more efficient than naproxen at treating persistent pain after spinal surgeries.

The capsaicin 8% patch for neuropathic pain in clinical practice: a retrospective analysis.

OBJECTIVE: To investigate the response of patients with peripheral neuropathic pain (PNP) to capsaicin 8% patch treatment in a clinical setting. DESIGN: Retrospective analysis. SETTING: The Clinic for Pain Therapy and Palliative Medicine at the Medical Centre for the region of Aachen, Germany. SUBJECTS: Patients diagnosed with PNP who attended the clinic for capsaicin 8% patch treatment between January 13, 2010 and February 7, 2011. OUTCOME MEASURES: Pain intensity was assessed using the Numeric Pain Rating Scale (NPRS) at baseline and following each capsaicin 8% patch treatment. Changes in prescribed concomitant neuropathic pain (NP) medications and response duration were recorded. RESULTS: Overall, 68 patients with PNP conditions, including facial neuropathy (severe trigeminal neuralgia in V2), polyneuropathy, post-herpetic neuralgia, and mononeuropathies, received 96 treatments with the capsaicin 8% patch. The 53 patients with a follow-up of ≥8 weeks demonstrated a 48.4% mean reduction in NPRS score from baseline to Weeks 1-8. Among the 37 responders (those exhibiting ≥30% reduction in NPRS score from baseline to Weeks 1-8), the median time to re-treatment was 125 days. Following treatment, there was a significant (P < 0.001) 54% reduction in the mean number of prescribed concomitant NP medications taken by patients. CONCLUSIONS: This analysis demonstrates that in clinical practice, the capsaicin 8% patch provides rapid and sustained pain reductions in patients with a variety of PNP conditions and a significant reduction in prescribed concomitant NP medications. The capsaicin 8% patch can be a valuable addition to the NP treatment armory for certain patients.

Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study.

OBJECTIVES: This study evaluated efficacy and safety of bolus doses of ziconotide (Prialt®, Eisai Limited, Hertfordshire, UK) to assess the option of continuous administration of this drug via an implanted intrathecal drug delivery system. MATERIALS AND METHODS: Twenty adults with severe chronic pain who were under consideration for intrathecal (IT) therapy were enrolled in this open label, nonrandomized, pilot study. Informed consent was obtained. Demographics, medical/pain history, pain scores, and concomitant medications were recorded. A physical examination was performed. Creatine kinase was measured. Initial visual analog scale (VAS), blood pressure, heart rate, and respiratory rate were recorded. All patients received an initial bolus dose of 2.5 mcg ziconotide; the dose in the subsequent visits was modified according to response. Subsequent doses were 2.5 mcg, 1.2 mcg, or 3.75 mcg as per protocol. A good response (≥30% reduction in baseline pain VAS) with no side-effects on two occasions was considered a successful trial. Data were analyzed using a generalized estimating equations model, with pain VAS as the outcome and time (seven time points; preinjection and one to six hours postinjection) as the predictor. RESULTS: Generalized estimating equations analysis of summary measures showed a mean reduction of pain VAS of approximately 25% at the group level; of 11 responders, seven underwent pump implantation procedure, two withdrew because of adverse effects, one refused an implant, and one could not have an implant (lack of funding from the Primary Care Trust). CONCLUSIONS: Our data demonstrated that mean VAS was reduced by approximately 25% at the group level after IT ziconotide bolus. Treatment efficacy did not vary with sex, center, age, or pain etiology. Ziconotide bolus was generally well tolerated. Larger studies are needed to determine if bolus dosing with ziconotide is a good predictor of response to continuous IT ziconotide via an intrathecal drug delivery system.

Subarachnoid haemorrhage associated with an intrathecal catheter.

Although 15 to 20 percent of patients with subarachnoid haemorrhage (SAH) do not have a vascular lesion on four-vessel cerebral angiography, venous injury is a potential cause. This case describes an intracranial catheter associated with nonaneurysmal SAH. It suggests that intrathecal catheters can cause vascular injury, and that nonaneurysmal perimesencephalic SAH may be due to injury of small blood vessels.

Disability Pension Did Not Reduce Opioid Use Among Patients With Failed Back Surgery Syndrome Who Were Trialed and Implanted for Spinal Cord Stimulation.

BACKGROUND: Spinal cord stimulation (SCS) is an effective treatment for failed back surgery syndrome (FBSS). In patients with FBSS, opioids have often been initiated, even before SCS is trialed. OBJECTIVE: We studied the effect of retirement on opioid use in patients with chronic pain after failed back surgery. STUDY DESIGN: A retrospective study design. SETTING: The study was conducted at Kuopio University Hospital. METHODS: The study group consisted of all 230 patients with SCS trialed or implanted for FBSS at Kuopio University Hospital Neurosurgery from January 1, 1996 through December 31, 2014. All purchases of prescribed opioids and their daily defined doses, as well as data on working ability, were obtained from the Social Insurance Institution. Patients were divided into 3 groups: SCS trial only, SCS implanted permanently, and SCS implanted but later explanted. We analyzed the differences in opioid use among these groups 2 years before and 2 years after the start of their disability pension (DP). RESULTS: During the follow-up period, a total of 60 patients received a DP. One year before DP, the majority of patients used opioids (n = 43, 72%), and throughout the one-year follow-up after retirement, the number of users increased slightly (n = 46, 77%). In the permanently implanted SCS group, the number of strong opioid users decreased after retirement. Most patients used a moderate dose (0.1-10.5 morphine milligram equivalent/d). Retirement appeared to interrupt dose escalation in all groups, but doses increased further as the follow-up continued. LIMITATIONS: No structured questionnaires were used in this study. Also, many underlying factors contributing to chronic pain were missing. CONCLUSIONS: DP did not reduce the use of opioids in patients with FBSS. Opioid doses were lower and dose escalation less steep with continuous SCS therapy.