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Background The obturator nerve runs along the posterolateral walls of the bladder and electrosurgical stimulation in this region can result in adductor spasm which can occur suddenly and unexpectedly with potentially catastrophic results. Methods Sixty patients were prospectively randomized to receive either a single-injection ultrasound-guided obturator nerve block (ONB) or intravenous rocuronium after induction of general anesthesia (i.e. neuromuscular block [NMB]). The primary objective was to compare the incidence of adductor spasm during posterolateral bladder tumor resection when ONB or NMB was used. Secondary objectives included assessment of fall risk and incidence of adverse events. Results Five patients in the ONB group and six in the NMB group had nonlateral wall lesions. One patient in the ONB group suffered a cardiac arrest after induction of general anesthesia. Of the remaining 48 patients, six (10.2%) experienced adductor spasm. Most of these patients were in the NMB group (5/24, 20.8%), with only one patient (1/24, 4.2%) experiencing obturator reflex in the ONB group; this difference was not statistically significant (P =0.19). Patients in the ONB group had a greater decrease in mean hip adductor strength. Our study population was found to be at high risk of falls before surgery. There were no statistically significant group differences in the Timed Up and Go test, with time to perform the test increasing in both groups. Conclusions Both techniques are safe and efficacious for preventing adductor spasm. Our data and experience suggest that the ONB is relatively easy to perform and should be considered in patients with posterolateral bladder tumors. [ABSTRACT FROM AUTHOR]

Objectives Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). Methods Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. Results The primary end point (change in NRS ± SD at week 8 vs baseline) was –0.94 ± 1.33 in the AT-02 group and –0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (–0.73, 95% confidence interval = –1.56 to 0.11, P  = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P  = 0.039). Conclusions The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging. [ABSTRACT FROM AUTHOR]

Objective. This study aims to assess diaphragmatic excursion and measure pulmonary functions as measures of the degree to which the phrenic nerve is blocked after ISB with two different concentrations of ropivacaine: 0.2% and 0.1%. Design. Randomized, double-blinded study. Setting and Patients. Ambulatory surgical facility. Subjects. Fifty patients undergoing shoulder arthroscopy for rotator cuff repair. Methods. Patients were randomized to receive ultrasound-guided ISB with 20mL of either 0.2% or 0.1% ropivacaine. Diaphragmatic excursion was measured using M-mode ultrasound. Pulmonary functions were assessed by portable spirometer. Additional outcome data included oxygen saturation in post-anesthesia care unit (PACU), pain scores, quality of recovery scores (QOR), and opioid consumption over 72hour period after surgery. Results. Forced vital capacity (FVC) was significantly reduced 30minutes after block placement and in PACU in the 0.2% group when compared with the 0.1% group (P=0.04, P= 0.03, respectively). Forced expiratory volume (FEV1) was also significantly decreased in the 0.2% group in PACU when compared with the 0.1% group (P=0.04). There were no significant differences in pain scores, length of stay, and total opioid consumption in PACU. Patients who received 0.2% ropivacaine had a longer block duration (18 vs 11.9hours, P=0.04) and used less opioid in the 72hours after surgery (55mg vs 102mg codeine equivalents, P=0.02), when they were compared to their counterparts who received 0.1% for their block. Conclusion. 0.1% ropivacaine may impair pulmonary function less than 0.2% ropivacaine. The clinical significance of these differences needs to be further studied. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the effectiveness of a modified interlaminar (MIL) approach for accessing ventral epidural space compared with the transforaminal (TF) approach. Study Design. Randomized double blinded control trial Methods. Eighty-four patients with lumbar radicular pain were randomly assigned into two groups in which drug delivery to the ventral epidural space was performed through either the MIL (n542) or the TF approach (n542). Within each group, subgroups were classified according to the dominant pathology as assessed by magnetic resonance imaging (MRI): bulging disc, herniated nucleus pulposus (HNP), and foraminal stenosis. Degenerative changes such as scoliosis and facet hypertrophy was also evaluated. Results. The overall accessibility to the ventral epidural space was similar between the two groups. In cases with foraminal stenosis, the success rate of ventral epidural spreading was significantly higher in the MIL group compared with the TF group (TF approach 5 50.00% vs MIL approach 5 100.00%, P 5 0.013). Medial spread of contrast was more dominant in the MIL group (P < 0.001). There was no significant difference between the two groups in overall clinical outcome. The total success rate of accessing the ventral epidural space in degenerative bony changes was higher in the MIL group than in the TF group (TF approach 5 57.1% vs MIL approach 5 84.6%), but the difference was not statistically significant. Conclusion. In cases where access to the ventral epidural space by conventional approach is limited, our MIL approach can be considered a suitable alternative, especially in the case of foraminal stenosis. [ABSTRACT FROM AUTHOR]

An international double-blind randomized placebo controlled study evaluated the safety and efficacy of four doses of a new sustained release naloxone capsule to treat Opioid Induced Constipation (OIC). Methods Forty patients taking opioids for noncancer related pain, and experiencing OIC, were randomized into 4 cohorts of 10 patients. A multiple ascending dose design was used to evaluate the safety and efficacy of 2.5 mg, 5 mg, 10 mg, and 20 mg naloxone sustained release (NSR) capsules vs placebo. Drug was given once-daily for 3 weeks followed by twice daily (bid) dosing between weeks 4 and 6. Results The incidence of treatment emergent adverse events was highest in the placebo group. The incidence of adverse events among the four active treatment groups were similar. There were no serious adverse events. The number of severe events was low overall but highest in the placebo group. Significant improvements were seen in Spontaneous Bowel Movements with 5 mg, 10 mg, and 20 mg NSR capsules. Mean change in SBMs from baseline of 2.21 ( P = 0.052), 2.37 ( P = 0.032); 4.11 ( P = 0.0005); 5.19 (<0.0001) was noted with NSR 2.5 mg, 5 mg, 10 mg, and 20 mg, respectively, when taken once daily, compared with 1.38 ( P = 0.2) for patients on placebo therapy. No changes in subjective or objective measures of opioid withdrawal as measured by the Subjective Opioid Withdrawal Scale or Clinical Opioid Withdrawal Scale were observed. There was no increase in patient reported pain as measured daily using a visual analogue scale. Conclusions This Phase II study has shown that using a new sustained release formulation to deliver oral naloxone to the colon allows successful treatment of OIC without comprising the desired opioid effects. [ABSTRACT FROM AUTHOR]

Introduction Discogenic low back pain ( LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty ( IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group. Methods Physical function, pain relief, and disability were assessed using the Short Form-36, numerical rating scale, and Oswestry Disability Index, respectively. Subjects were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB. Results Twenty-two out of 27 subjects in the original active treatment group were followed until 12 months and had clinically significant improvements in physical function (Δ = 22) and pain (Δ = −2.9). Out of 30 subjects originally in the sham group, 24 chose to cross over, and 20 cross-over patients completed follow-up at 6 months. In cross-over patients, improvements in physical function and pain did not differ statistically from those of patients originally randomized to IDB treatment. No complications or adverse events related to the procedure were reported. Conclusions Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at all observed time points. [ABSTRACT FROM AUTHOR]

Objectives The objective of this study was to determine the effects of combining pulsed radiofrequency ( PRF) treatment and transforaminal epidural injection ( TFEI) to treat patients with chronic refractory lumbar radicular pain caused by lumbar spinal stenosis. Study design Randomized control trial. Settings Interventional pain management practice. Method Sixty-two patients were assigned to the study groups ( PRF group = 31; control group = 31). Under fluoroscopic guidance, the RF needle was positioned close to the lumbar dorsal root ganglion. The PRF group received 3 cycles of PRF treatment, and sensory stimulation without RF lesioning was applied to the control group. After PRF or sham lesioning, a local anesthetic with steroid was injected. The primary outcome of a successful response was defined as: 1) ≥50% or 4-point pain reduction in the numerical rating scale ( NRS) without an increase in the Oswestry disability index ( ODI) or medication quantification scale ( MQS), or mean score <4 in the global perceived effect ( GPE) scale; or 2) ≥30% or 2-point pain reduction in NRS with a simultaneous decrease in ODI, MQS, or ≥6 points in the GPE scale. Result The number of patients with successful treatment results was higher in the PRF group at 2 months ( P = 0.032) and 3 months ( P = 0.018). No significant differences were observed in terms of the secondary outcome variables between the 2 groups. Conclusion The TFEI provided significant short-term pain relief and PRF can be applied in conjunction with TFEI to achieve higher treatment efficacy compared with TFEI alone. [ABSTRACT FROM AUTHOR]

Objective A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP). Methods This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20−100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction ( Subject Global Assessment of Medication) were assessed. Results Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids. Conclusions Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP. [ABSTRACT FROM AUTHOR]