Efficacy and safety of sublingual fentanyl tablets for the management of breakthrough pain in patients with chronic musculoskeletal pain with neuropathic component: multicenter prospective study.

BACKGROUND AND OBJECTIVE: Despite its prevalence and impact, breakthrough pain (BTP) in chronic non-cancer pain with neuropathic component, has not been well studied and is sometimes unrecognized and often undertreated. We evaluated the efficacy of sublingual fentanyl tablet (SLF) for the treatment of BTP in opioid-tolerant patients with chronic musculoskeletal pain with neuropathic component in terms of relief of pain intensity and assessed whether hypothetical pain relief impacts on quality of life (QoL). METHODS: A multicenter, prospective, open-label study was conducted over a 30-day period. Efficacy was evaluated using a visual analogue scale (VAS) and time to onset of action of SLF. The incidence of dependence was assessed by the Leeds Dependence Questionnaire (LDQ). Changes in QoL were evaluated using the Brief Pain Questionnaire (BPI) and the EuroQol (EQ-5D). Adverse events (AE) were recorded throughout. RESULTS: 106 patients were enrolled and 105 completed the study. The average pain reduction across the study was -3.30 points [95 % confidence interval (CI) 2.9-3.7; P < 0.0001]. Pain intensity improvement from baseline was statistically significant at first assessment and all subsequent assessments (P < 0.0001). The most common AEs included nausea (33.87 %), constipation (33.06 %), somnolence (19.35 %) and vomiting (6.45 %). No significant differences were observed on LDQ (P = 0.71). QoL as measured by BPI showed statistically significant improvement in all four severity items and all interference items (P < 0.0001) and a significant improvement in the percentage of pain relief reported by patients (P < 0.0001). EQ-5D results showed a trend towards improvement. Mean self-rate health status, as measured by the EQ VAS scale increased significantly (P < 0.0001). CONCLUSION: SLF provides significant reductions in BTP intensity. The results of the BPI and EQ-5D assessments indicate that pain relief is associated with improvement of functioning and enhancement of QoL.

Controlled clinical trial with pirfenidone in the treatment of breast capsular contracture: association of TGF-ß polymorphisms.

BACKGROUND: Breast capsular contracture (BCC) is a commonly adverse event postmammoplastly characterized by an immune response mediated by cytokines and transforming growth factor (TGF)-ß1 resulting in excessive synthesis and deposit of extracellular matrix around the breast implant. Presence of TGF-ß1 polymorphisms has been associated as a risk factor to develop fibroproliferative diseases. METHODS: This open, controlled, prospective, and pilot clinical trial with 6 months duration was carried out to evaluate the efficacy of 1800 mg a day, of oral Pirfenidone (PFD) in the treatment of BCC (Baker Score III/IV) postmammoplasty. Twenty BCC cases received PFD and 14 BCC control cases underwent capsulectomy after 6 months of enrollment. Both groups were followed up for 6 more months up to 12 months to determine the relapse in the absence of PFD. Determination of TGF-ß1 polymorphisms was performed to establish a correlation with capsular contracture. RESULTS: PFD group experienced BCC-reduction in all breasts 6 months after enrollment. Only 1 of 20 cases relapsed after follow-up. In capsulectomy group, 2 of 14 cases presented progression to grade IV during presurgical period. All capsulectomy cases relapsed at end of follow-up. Nearly hundred percent of all patients studied in this protocol had a profibrogenic homozygous TGF-ß1 polymorphism (codon 25; genotype Arg25Arg). CONCLUSIONS: PFD is useful to improve BCC (Baker Score III/IV) postmammoplasty with no relapse after drug administration. There is also an association between capsular contracture and the presence of homozygous G/G TGF-ß1 genotype.

[Caudal duplication: case report]. / Duplicación caudal: reporte de caso.

BACKGROUND: The caudal duplication syndrome is defined by the association between gastrointestinal, genitourinary, and distal neural tube malformations and duplications. We presented a case report and the possible embryologic origin is discussed. CLINICAL CASE: We describe a twenty-one year female patient, with clinical and imaging diagnosis of caudal duplication. She has normal psychomotor development. CONCLUSIONS: The current case integrates a Caudal Duplication with no alteration of the spinal column. We propose that this malformation result from an insult in the primitive hindgut.

Needle-induced paresthesiae during single-shot spinal anesthesia: a comparison of sitting versus lateral decubitus position.

BACKGROUND AND OBJECTIVES: Paresthesiae occasionally occur during spinal puncture or injection of local anesthetic for spinal anesthesia. No information is currently available regarding the effects of the patient's position on the incidence of needle-induced paresthesiae. The purpose of this prospective, observational study was to compare the occurrence of needle-induced paresthesiae in patients who received single-shot spinal anesthesia in the sitting position or in the lateral decubitus position. METHODS: A total of 620 patients operated on under spinal anesthesia were included. Spinal anesthesia was performed in the sitting position in 142 patients and in the lateral decubitus position in 478 patients. All blocks were performed with a 25-gauge, 90-mm, Sprotte needle, at the L3-L4 or L4-L5 level. Patients' demographics, patients' position (lateral decubitus or sitting), number of skin punctures, incidence of paresthesiae, and success of the anesthesia were recorded. RESULTS: The overall incidence of paresthesiae was higher in the lateral decubitus position (16.95%) compared with the sitting position (9.15%) (P = 0.0230). The number of punctures and the success rate were similar in both positions. Studying the incidence of paresthesiae for each position, when performing 1 or more punctures, there was no position-related difference noted if a single-needle puncture was sufficient to perform the block (8.0% in the lateral decubitus group versus 5.1% in the sitting group) (P = 0.3305). This difference between positions was significant when more than a single-needle puncture was required (34.1% in the lateral decubitus group versus 18.6% in the sitting group) (P = 0.0497). CONCLUSIONS: Patient's position may influence the occurrence of needle-induced paresthesiae during spinal anesthesia. Lateral decubitus position resulted in a higher incidence of paresthesiae than the sitting position. However, there is no position-related difference noted if a single-needle puncture is sufficient to perform the block.

Comparison of continuous infusion versus automated bolus for postoperative patient-controlled analgesia with popliteal sciatic nerve catheters.

BACKGROUND: This investigation was designed to compare a new methodology of automated regular bolus with a continuous infusion of local anesthetic for continuous popliteal sciatic block; both regimens were combined with patient-controlled analgesia (PCA). METHODS: Fifty patients undergoing hallux valgus repair were randomly allocated to receive an infusion of 0.125% levobupivacaine administered through a popliteal catheter as an automated regular bolus (n = 25) or as a continuous infusion (n = 25), both combined with PCA. Postoperative pain scores, incremental doses delivered by the PCA, local anesthetic consumed per hour, and the need for rescue tramadol analgesia were recorded. RESULTS: Both dosing regimens provided similar postoperative analgesia. Consumption of local anesthetic (5.14 ml/h, 5-5.75 ml/h) and dose request from the PCA (1, 0-5.4) was lower in the automated bolus group as compared to the continuous infusion group (5.9 ml/h, 5.05-7.8 ml/h; doses by PCA: 6.5, 0-20.5; P < 0.05). The need for rescue tramadol was similar in the two groups. CONCLUSION: In continuous popliteal sciatic block, local anesthetic administered as an automated regular bolus in conjunction with PCA provided similar pain relief as a continuous infusion technique combined with PCA; however, the new dosing regimen reduced the need for additional PCA and the overall consumption of local anesthetic.

A "new" automated bolus technique for continuous popliteal block: a prospective, randomized comparison with a continuous infusion technique.

BACKGROUND: We designed the present, prospective, randomized, double-blind study to compare the administration of an automated intermittent bolus dose with a conventional technique of continuous infusion of local anesthetic for postoperative analgesia in continuous popliteal sciatic nerve blockade. METHODS: Forty-four patients undergoing hallux valgus repair were randomly assigned to receive either a continuous infusion of 0.125% levobupivacaine with an infusion rate of 5 mL/h (continuous infusion group, n=22) or automated bolus doses of 5 mL every hour of the same local anesthetic (automated bolus group, n=22) for 24 h. Postoperative pain scores were assessed using a verbal rating pain score. The amount of rescue tramadol medication for pain was also recorded. RESULTS: In patients of the automated bolus group there was a reduction in pain scores (P<0.05) during the postoperative period, when compared to patients of the continuous infusion group. Five patients in the automated bolus group (24%) and 11 patients of the continuous group (52%) required rescue tramadol analgesia (P=0.055). CONCLUSION: The present investigation demonstrated that local anesthetic administered by an automated bolus technique provided better postoperative pain relief than a continuous infusion technique for continuous popliteal nerve block after foot surgery.

Radial plus musculocutaneous nerve stimulation for axillary block is inferior to triple nerve stimulation with 2% mepivacaine.

STUDY OBJECTIVE: To compare the extent of sensory and motor block with two different nerve stimulation techniques in axillary blocks. DESIGN: Prospective, randomized, investigator-blinded study. SETTING: Ambulatory surgery unit of a university hospital. PATIENTS: 60 ASA physical status I, II, and III patients undergoing surgery at or below the elbow. INTERVENTIONS: Patients receiving axillary block were randomized into two nerve stimulation groups with either radial plus musculocutaneous or triple nerve stimulation (radial, median, and musculocutaneous nerves). Thirty milliliters of plain 2% mepivacaine was given to all patients either in a single or fractionated dosing for radial or for radial and median nerves, according to group assignment. Five milliliters of plain 1% mepivacaine for the musculocutaneous nerve was given to all patients. MEASUREMENTS: Blocks were assessed at 10, 20, and 30 minutes. Rates of supplementation given as a result of insufficient surgical anesthesia were also noted. MAIN RESULTS: Statistically significantly higher rates of anesthesia at the cutaneous distributions of median and medial cutaneous of the arm nerves with multiple nerve stimulation at 30 minutes were found as compared with radial plus musculocutaneous nerve stimulation. The rate of supplementation was lower with multiple nerve stimulation. CONCLUSIONS: Radial plus musculocutaneous nerve stimulation showed lower efficacy of axillary block than did triple nerve stimulation when using 2% mepivacaine.

Lateral approach to the sciatic nerve in the popliteal fossa: a comparison between 1.5% mepivacaine and 0.75% ropivacaine.

BACKGROUND AND OBJECTIVES: Ropivacaine and mepivacaine are commonly used local anesthetics for peripheral nerve blockade. The purpose of the present study was to compare onset time, quality of anesthesia, and duration of analgesia with ropivacaine 0.75% and mepivacaine 1.5% for lateral popliteal nerve block. METHODS: Fifty American Society of Anesthesiologists (ASA) physical status I or II patients scheduled for foot and ankle surgery with calf tourniquet under lateral popliteal sciatic nerve block were randomly assigned to receive 30 mL of either ropivacaine 0.75% or mepivacaine 1.5%. Time required for onset of sensory and motor block, resolution of motor blockade, onset of postsurgical pain, and time of first analgesic medication were recorded. RESULTS: The 2 groups were similar with regard to demographic variables and duration of surgery. Onset of sensory and motor block was significantly shorter in the mepivacaine group (9.9 +/- 3.3 min and 14.7 +/- 3.6 min, respectively) than in the ropivacaine group (18.1 +/- 6.1 min and 23.6 +/- 5.5 min, respectively) (P < 0.001). Resolution of motor block occurred later in the ropivacaine group than in the mepivacaine group (P < 0.001), and duration of postoperative analgesia was significantly longer in the ropivacaine group (19 +/- 3.4 h) compared with the mepivacaine group (5.9 +/- 1.1 h) (P < 0.001). Analgesic requirements were higher in mepivacaine group than in the ropivacaine group (P < 0.001). There were 2 failed blocks, one in each group. CONCLUSIONS: Both ropivacaine and mepivacaine provided effective sciatic nerve blockade. Mepivacaine 1.5% displayed a significantly shorter onset time than ropivacaine 0.75%. Postoperatively, ropivacaine 0.75% resulted in longer-lasting analgesia and less need for oral pain medication.