Nebulized lignocaine for topical anaesthesia in no-sedation bronchoscopy (NEBULA): A randomized, double blind, placebo-controlled trial.
ABSTRACT: Background:The role of nebulized lignocaine administration for flexible bronchoscopy is unclear. Methods:In this randomized, double-blind, placebo-controlled trial, subjects undergoing diagnostic flexible bronchoscopy were randomized to receive either nebulized lignocaine (2.5 ml of 4% lignocaine) or nebulized (2.5 ml of 0.9%) saline (placebo). All received 10% lignocaine pharyngeal spray (4 sprays) and 5-ml nasal 2% lignocaine gel. 1% lignocaine solution was used for spray-as-you-go administration in all. Co-primary outcomes were Operator-rated overall procedure satisfaction and Operator-rated cough scores on Visual Analog Scale (VAS). Secondary objectives were cumulative lignocaine dose, proportion of subjects receiving >8.2-mg/kg lignocaine, and complications between the groups. Results:Two hundred and twenty subjects were randomized and 217 (109 - nebulized lignocaine and 108 - placebo) received the intervention. Baseline characteristics were comparable. Operator-rated overall procedure satisfaction scores on VAS (7.30 ± 1.54 nebulized lignocaine and 7.50 ± 1.31 placebo group,P = 0.85) and Operator-rated cough scores on VAS (3 [2-5] nebulized lignocaine and 3 [2-4] placebo group,P = 0.18) were similar. Cumulative lignocaine dose was significantly greater in nebulized lignocaine group (331.46 ± 9.41 mg vs. 232.22 ± 12.77 mg,P < 0.001), and a significantly greater number of subjects in this group received lignocaine dose >8.2 mg/kg. Minor complications occurred in 6 and 9 subjects in nebulized lignocaine and placebo groups, respectively,P = 0.41. Conclusion:Administration of nebulized lignocaine in addition to pharyngeal lignocaine spray, during no-sedation bronchoscopy, increases the cumulative lignocaine dose without improved procedural comfort. Additional nebulized lignocaine during bronchoscopy is not recommended.
Project description:Background and Objectives:No previous study has compared different concentrations of lignocaine for topical anesthesia during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this pilot study, we compared 1% versus 2% lignocaine for topical airway anesthesia during EBUS-TBNA. Methods:In this double-blind, randomized trial, subjects were randomized to receive either 1% or 2% lignocaine for "spray-as-you-go" administration. All received combined moderate intravenous sedation (midazolam and fentanyl). Ten percent pharyngeal lignocaine spray (two sprays) and nebulized lignocaine (2.5 ml of 4% solution) were administered to all subjects. Administration of additional lignocaine was allowed at operator's discretion. The primary endpoints were operator-rated overall procedural satisfaction and cough, each assessed on visual analog scale (VAS), while the secondary outcomes included patient-rated faces pain scale scores, cumulative lignocaine dose, number of subjects receiving lignocaine >8.2 mg/kg, doses of midazolam/fentanyl between groups, and adverse events during procedure. Results:The mean (standard deviation [SD]) VAS scores for operator-rated procedure satisfaction were 64.2 (25.6) and 68.7 (23.7) in 1% and 2% group, respectively (P = 0.35). The median (interquartile range) VAS scores for operator-rated cough were 48.4 (23.9-69.9) in 1% group and 38.7 (18.6-69.5) in 2% group (P = 0.24). The mean [SD] cumulative lignocaine received in the 2% lignocaine group (248.6 [29.1] mg) was significantly greater than in 1% lignocaine group (178.5 [14.6] mg) (P < 0.01). Conclusion:One percent lignocaine is equally efficacious as 2% lignocaine for topical anesthesia during EBUS-TBNA, at a significantly lower cumulative lignocaine dose.
Project description:INTRODUCTION:Topical airway anesthesia is known to improve tolerance and patient satisfaction during flexible bronchoscopy (FB). Lidocaine is commonly used, delivered as an atomized spray. The current study assesses safety and patient satisfaction for nasal anesthesia of a new atomization device during outpatient bronchoscopy in lung transplant recipients. METHODS:Using a prospective, non-blinded, cross-over design, patients enrolled between 01-10-2014 and 24-11-2014 received 2% lidocaine using the standard reusable nasal atomizer (CRNA). Those enrolled between 25-11-2014 and 30-01-2015, received a disposable intranasal mucosal atomization device (DIMAD). After each procedure, the treating physician, their assistant and the patient independently rated side-effects and satisfaction, basing their responses on visual analogue scales (VAS). At their next scheduled bronchoscopy during the study period, patients then received the alternative atomizer. Written consent was obtained prior to the first bronchoscopy, and the study approved by the institutional ethics committee. RESULTS:Of the 252 patients enrolled between 01-10-2014 and 30-01-2015, 80 (32%) received both atomizers. Physicians reported better efficacy (p = 0.001) and fewer side effects (p< = 0.001) for DIMAD in patients exposed to both procedures. Among patients with one visit, physicians and their assistants reported improved efficacy (p = 0.018, p = 0.002) and fewer side effects (p< = 0.001, p = 0.029) for the disposable atomizer, whereas patients reported no difference in efficacy or side effects (p = 0.72 and p = 0.20). No severe adverse events were noted. The cost of the reusable device was 4.08€ per procedure, compared to 3.70€ for the disposable device. DISCUSSION:Topical nasal anesthesia via a disposable intranasal mucosal atomization device (DIMAD) offers comparable safety and patient comfort, compared to conventional reusable nasal atomizers (CRNA) in lung transplant recipients. Procedural costs were reduced by 0.34€ per procedure. TRIAL REGISTRATION:clinicaltrials.gov NCT02237651.
Project description:570 patients with acute ankle joint distortion were randomized to four treatment groups: a combination spray of arnica tincture and hydroxyethyl salicylate (HES; group A, n = 228), arnica (B, n = 57), HES (C, n = 228), and placebo (D, n = 57). The medication was applied 4-5 times daily for 10 days. Efficacy was assessed on day 3-4 by evaluating pain on motion on a visual analogue scale (VAS). Pain improvement in group A was significantly superior over groups B-D (t-test with unadjusted baseline values, P < 4 × 10(-7) and ANCOVA after adjustment, P < 5 × 10(-11)) and approximately corresponded to the cumulative effect of the single constituents (12.1, 7.5, and 18.7?mm VAS for A versus B, A versus C, and A versus D; 95% CI 8.0-16.2, 4.7-10.4, and 14.8-22.5?mm). The combination is justified by the additive effects of the single active constituents.
Project description:INTRODUCTION:Double J (DJ) stents are often removed under local anesthesia using a rigid cystoscope. Patients experience significant pain during this procedure and also continue to have discomfort during voiding for a few days. We assessed the efficacy and safety of preemptive oral diclofenac in pain relief in patients undergoing DJ stent removal (DJSR) by rigid cystoscopy compared to placebo. METHODS:Consecutive consenting male patients undergoing DJSR under local anesthesia between March 2014 and July 2015 were enrolled. Patients were randomized to receive 75 mg oral diclofenac (Group A) or placebo (Group B) 1 h before procedure by double-blind randomization. Intraurethral 2% lignocaine gel (25 ml) was used in both groups. Pain during rigid cystoscopy, pain at the first void, and at 24 h after cystoscopy was assessed using visual analog scale (VAS) (0-100). Adverse reactions to diclofenac and episodes of acute urinary retention, if any, were assessed (Trial registered at clinicaltrials.gov: NCT02598102). RESULTS:A total of 121 males (Group A [n = 62]; Group B [n = 59]) underwent stent removal. The median (Interquartile range) VAS during the procedure in Group A was 30 (30) and Group B was 60 (30) (P < 0.001), at first void was 30 (30) and 70 (30) (P < 0.001) and at 24 h postoperatively was 20 (20) and 40 (20) (P < 0.001). The incidence of epigastric pain, nausea, vomiting, and acute urinary retention was comparable in the two groups (P > 0.05). CONCLUSIONS:A single oral dose of diclofenac administered 1 h before DJSR using rigid cystoscope under intraurethral lignocaine anesthesia decreases pain significantly during and up to 24 h postprocedure with minimal side effects.
Project description:BACKGROUND:Intravenous morphine titration (IVMT) is the French gold standard for opioid treatment in the emergency department (ED). Nebulized morphine titration (NMT) may represent an alternative without venous access, but it has not been adequately studied in adults. We test the hypothesis that NMT is at least as effective as IVMT to initially manage severe acute pain in the ED. METHODS/DESIGN:We designed a multicenter (10 French EDs), single-blind, randomized and controlled trial. Adults between 18 and 75?years with visual analog scale (VAS)???70/100 or numeric rating scale (NRS)???7/10 will be enrolled. We will randomize 850 patients into two groups to compare two routes of MT as long as VAS?>? 30 or NRS?>? 3. In group A (425), patients will receive an initial NMT for 5-25?min associated with titration of an intravenously (IV) administered placebo of physiologic serum (PS). In group B (425), patients will receive IVMT plus nebulized PS placebo. NMT is defined as a minimum of 1 and a maximum of 3 5-min nebulized boluses of 10?mg or 15?mg (weight???60?kg), at 10-min fixed intervals. IVMT is defined as a minimum of 1 and a maximum of 6 boluses of 2?mg or 3?mg (weight???60?kg), at 5-min fixed intervals. Nebulized placebo titration will be performed every 10?min. IV titration of PS will be performed every 5?min. In both groups, after 25?min, if VAS >?30/100 or NRS?>?3/10, routine IVMT will be continued until pain relief. Pain severity, vital signs, bronchospasm, and Ramsay score will be recorded every 5?min. The primary outcome is the rate of relief obtained 1?h from the start of drug administration. Complete pain relief in both groups will be compared with a non-inferiority design. Secondary outcomes are pain relief at 30?min (the end of NMT) and at 2?h and median pain relief. We will compare final doses, and study the feasibility and tolerance of NMT (protocol deviations, respiratory or hemodynamic depression, sedation, and minor vegetative side effects). Co-analgesia will be recorded. Discharge criteria from the ED and hospital are defined. DISCUSSION:This trial is the first multicenter randomized and controlled NMT protocol for severe pain in the ED using the titration concept. We propose an original approach of combined titration with an endpoint at 1?h and a non-inferiority design. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03257319 . Registered on 22 August 2017.
Project description:Background and Aims:Myofascial pain syndrome (MPS) is a common cause of chronic musculoskeletal pain, characterised by myofascial trigger points (TPs). TP injection is an established technique for management of MPS. In this study, we analysed the efficacy of myofascial TP injection of lignocaine and the influencing biomechanical factors on MPS. Methods:After obtaining ethical committee approval, we included the first 100 adult patients of MPS with failed physical therapy aged above 18 years, and with TPs in the trapezius, infraspinatus, and/or the levator scapulae muscles and Visual analog scale (VAS) >4. TP injection of 2% (2 ml) lignocaine was performed. Visual analogue scale (VAS) scores were recorded immediately and after 1 month. Number of repeat TP injections and use of oral analgesic in one month was noted. Results were analysed with the analysis of variance test. Results:The mean VAS reduced significantly both immediately and 1 month after therapeutic injections (8.57 ± 0.77, 2.67 ± 1.43 and 2.82 ± 1.4, respectively, P < 0.01). Keeping the palm below the head during sleep was the major contributing factor for myofascial TP, followed by slanting the neck to use mobile phones. Repeat TP injection was used in 4% of cases. Conclusion:TP injection of 2 ml of 2% lignocaine along with correction of predisposing biomechanical factors provided significant pain relief for MPS in patients with failed physical therapy without any side effects.
Project description:BACKGROUND:Endobronchial administration of lidocaine is commonly used for cough suppression during diagnostic bronchoscopy. Recently, nebulization of lidocaine during bronchoscopies under deep sedation with fiberoptic intubation using a distinct spray catheter has been shown to have several advantages over conventional lidocaine administration via syringe. However, there are no data about this approach in bronchoscopies performed under moderate sedation. Therefore, this study compared the tolerability and safety of nebulized lidocaine with conventional lidocaine administration via syringe in patients undergoing bronchoscopy with moderate sedation. METHODS:Patients requiring diagnostic bronchoscopy were randomly assigned to receive topical lidocaine either via syringe or via nebulizer. Endpoints were consumption of lidocaine and sedative drugs, as well as patient tolerance and safety. RESULTS:Sixty patients were included in the study (n?=?30 in each group). Patients required lower doses of endobronchial lidocaine when given via nebulizer versus syringe (164.7?±?20.8 mg vs. 250.4?±?42.38 mg; p?<?0.0001) whereas no differences in the dosage of sedative drugs were observed between the two groups (all p?>?0.05). Patients in the nebulizer group had higher mean oxygen saturation (96.19?±?2.45% vs. 94.21?±?3.02%; p?=?0.0072) and a lower complication rate (0.3?±?0.79 vs. 1.17?±?1.62 per procedure; p?=?0.0121) compared with those in the syringe group. CONCLUSIONS:Endobronchial lidocaine administration via nebulizer was well-tolerated during bronchoscopies under moderate sedation and was associated with reduced lidocaine consumption, a lower complication rate and better oxygenation compared with lidocaine administration via syringe. TRIAL REGISTRATION:The study was registered with clinicaltrials.gov ( NCT02262442 ; 13th October 2014).
Project description:The objective of this study was to report the serum concentration of lignocaine after pertubation in patients with endometriosis.Prospective observational study.The study was carried out at a gynaecological outpatient unit in Stockholm, Sweden.Eligible patients had endometriosis with a dysmenorrhoic pain score of >50 mm on a visual analogue scale, and patent fallopian tubes.Patients with endometriosis (n = 25) were included in the study. The patients received pre-ovulatory pertubations with lignocaine hydrochloride 10 mg (n = 16) or ringer acetate (placebo, n = 9). The procedure comprised passing the study solution through the uterus and the fallopian tubes via an intra-cervical balloon catheter. Serum samples were collected at 0, 5, 15 and 30 min after pertubation.The serum samples were analysed for the concentration of lignocaine with an LCMS-SIM method.Low levels of lignocaine were detected in the serum samples following pertubation of 10 mg lignocaine hydrochloride. The highest observed concentration was seen after 30 min (mean 0.050 ?g/ml), with an individual maximum of 0.124 ?g/ml. Maximum concentration (C max) and time to C max (T max) could not be calculated, since the highest values were observed in the 30-min samples, which was the last sample obtained. Lignocaine was not detected after pertubation with placebo.The serum levels of lignocaine following pertubation of 10 mg lignocaine hydrochloride are detectable but low. Lignocaine pertubated through the fallopian tubes reaches the peritoneal cavity and diffuses through the peritoneum into the blood circulation. Pertubation with lignocaine is safe and has no lignocaine-related adverse events.
Project description:Importance:In therapeutic trials for acute viral bronchiolitis, consistent clinical improvement in groups that received nebulized normal saline (NS) as placebo raises the question of whether nebulized NS acts as a treatment rather than a placebo. Objective:To measure the short-term association of nebulized NS with physiologic measures of respiratory status in children with bronchiolitis by analyzing the changes in these measures between the use of nebulized NS and the use of other placebos and the changes before and after nebulized NS treatment. Data Sources:MEDLINE and Scopus were searched through March 2019, as were bibliographies of included studies and relevant systematic reviews, for randomized clinical trials evaluating nebulized therapies in bronchiolitis. Study Selection:Randomized clinical trials comparing children 2 years or younger with bronchiolitis who were treated with nebulized NS were included. Studies enrolling a treatment group receiving an alternative placebo were included for comparison of NS with other placebos. Data Extraction and Synthesis:Data abstraction was performed per PRISMA guidelines. Fixed- and random-effects, variance-weighted meta-analytic models were used. Main Outcomes and Measures:Pooled estimates of the association with respiratory scores, respiratory rates, and oxygen saturation within 60 minutes of treatment were generated for nebulized NS vs another placebo and for change before and after receiving nebulized NS. Results:A total of 29 studies including 1583 patients were included. Standardized mean differences in respiratory scores for nebulized NS vs other placebo (3 studies) favored nebulized NS by -0.9 points (95% CI, -1.2 to -0.6 points) at 60 minutes after treatment (P?<?.001). There were no differences in respiratory rate or oxygen saturation comparing nebulized NS with other placebo. The standardized mean difference in respiratory score (25 studies) after nebulized NS was -0.7 (95% CI, -0.7 to -0.6; I2?=?62%). The weighted mean difference in respiratory scores using a consistent scale (13 studies) after nebulized NS was -1.6 points (95% CI, -1.9 to -1.3 points; I2?=?72%). The weighted mean difference in respiratory rate (17 studies) after nebulized NS was -5.5 breaths per minute (95% CI, -6.3 to -4.6 breaths per minute; I2?=?24%). The weighted mean difference in oxygen saturation (23 studies) after nebulized NS was -0.4% (95% CI, -0.6% to -0.2%; I2?=?79%). Conclusions and Relevance:Nebulized NS may be an active treatment for acute viral bronchiolitis. Further evaluation should occur to establish whether it is a true placebo.
Project description:Objective:Evaluate the analgesic/antihyperalgesic effects of ASP9226, a state-dependent N-type voltage-gated calcium channel inhibitor, in healthy male subjects. Design:Randomized, double-blind, double-dummy, placebo- and active comparator-controlled crossover study. Setting:HPR Dr. Schaffler GmbH, Munich, Germany. Subject:Healthy male subjects aged 18-55?years. Methods:Twenty-four eligible subjects were randomly assigned to one of four treatment sequences and received single doses of ASP9226 (30?mg or 50?mg), pregabalin (150?mg), or placebo during four treatment periods. Laser-evoked potentials (LEP) and postlaser pain visual analog scales (VAS) on capsaicin-treated skin were assessed during main assessment days (the first day of each study period). Primary and secondary end points were the differences in LEP N2-P2 peak-to-peak (PtP) amplitudes and VAS score, respectively, in all subjects. Results:Overall, treatment with pregabalin resulted in a significantly lower LEP N2-P2 PtP amplitude vs placebo (-3.30??V, P?<?0.0001). There were no clinically relevant differences in N2-P2 PtP amplitudes between placebo and either ASP9226 dose (-0.31??V and -0.27??V). Furthermore, subjects reported significantly lower VAS pain scores with pregabalin vs placebo (-9.90%, P?<?0.0001) in contrast to ASP9226 30?mg (-2.1%) and ASP9226 50?mg (1.2%) vs placebo. Subgroup analysis of LEP and VAS pain in participants with positive prestudy capsaicin response (n?=?13) were in keeping with results in all subjects. Conclusions:ASP9226 was well tolerated; however, there was no improvement in LEP and VAS pain scores with ASP9226 at either dose vs placebo.