A descriptive study of the effect of a disciplinary proceeding decision on medical practitioners' practice behaviour in the context of providing a hydrocortisone and lignocaine injection.

INTRODUCTION: We conducted a descriptive study to evaluate any changes in practice behaviour regarding the provision of hydrocortisone and lignocaine (H&L) injections among doctors and how an H&L injection is priced following a disciplinary proceeding decision. A doctor had been fined SGD 100,000 for failing to obtain informed consent before an H&L injection. METHODS: We performed a survey shortly after the disciplinary decision to ascertain: (a) the category of the respondent; (b) whether the respondent provided H&L injections and how much he charged before the decision; and (c) after the decision. All members of the Singapore Medical Association and College of Family Physicians Singapore are doctors and were invited to participate. RESULTS: 1,927 doctors responded to the survey. Prior to the decision, 804 doctors did not perform H&L injections; this increased by 20.4% to 968 after the decision. The number of doctors who gave H&L injections decreased by 164 (14.6%), from the previous 1,123. Pre-decision, doctors who determined their own price for H&L injections charged a median pricing ≤ SGD 100. Post-decision, the median charge rose to > SGD 100 to SGD 200. At higher price bands, the number of doctors who charged > SGD 1,000 increased eight-fold, from eight to 65. CONCLUSION: The study demonstrated how a disciplinary decision can affect practice behaviour, and specifically how doctors may choose to not offer a service, an example of defensive medicine through avoidance behaviour. It also showed how prices for a service can rise following such a decision, which demonstrates the concept of negative general deterrence in sentencing.

Periprostatic nerve block alone versus combined with perineal pudendal nerve block or intrarectal local anesthesia during transrectal ultrasound-guided prostate biopsy: A prospective randomized controlled trial.

OBJECTIVES: To compare the efficacy, safety and cost of combinations of perineal pudendal nerve block + periprostatic nerve block and intrarectal local anesthesia + periprostatic nerve block with the standard technique (periprostatic nerve block). METHODS: The study was designed as a randomized prospective controlled trial. Patients with elevated serum prostate-specific antigen values (prostate-specific antigen ≥4 ng/mL) and/or abnormal digital rectal examination findings were included in the study. Patients with anorectal diseases, chronic prostatitis, previous history of prostate biopsy and anorectal surgery were excluded from the study. A total of 148 patients (group 1 [periprostatic nerve block], n = 48; group 2 [intrarectal local anesthesia + periprostatic nerve block], n = 51; group 3 [perineal pudendal nerve block + periprostatic nerve block], n = 49) were included in the final analysis. Pain during insertion and manipulation of the transrectal ultrasound probe was recorded as visual analog scale 1, pain during penetration of the biopsy needle into the prostate and sampling was recorded as visual analog scale 2, and pain during the entire procedure recorded as visual analog scale 3. RESULTS: The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001). There was no significant difference between the groups in terms of the mean visual analog scale 2 score. The mean visual analog scale 3 score was significantly lower in group 3 when compared with other groups (P < 0.001). The total cost for transrectal ultrasound-guided biopsy in the intrarectal local anesthesia + periprostatic nerve block group was significantly higher than the other two groups. CONCLUSIONS: The combination of perineal pudendal nerve block and periprostatic nerve block provides more effective pain control than intrarectal local anesthesia plus periprostatic nerve block and periprostatic nerve block alone, with similar complication rates and without increasing cost.

A randomised controlled trial of the clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injections: the hip injection trial (HIT) protocol.

BACKGROUND: Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection. METHODS: The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants' 'average' follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial. DISCUSSION: To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections. TRIAL REGISTRATION: ISRCTN: 50550256 , 28th July 2015.

Outcomes and cost-effectiveness of ultrasound-guided injection of the trochanteric bursa.

We hypothesized that ultrasound (US) guidance improves outcomes of corticosteroid injection of trochanteric bursitis. 40 patients with greater trochanteric pain syndrome defined by pain to palpation over the trochanteric bursa were randomized to injection with 5 ml of 1% lidocaine and 80 mg of methylprednisolone using (1) conventional anatomic landmark palpation guidance or (2) US guidance. Procedural pain (Visual Analogue Pain Scale), pain at outcome (2 weeks and 6 months), therapeutic duration, time-to-next intervention, and costs were determined. There were no complications in either group. Ultrasonography demonstrated that at least a 2-in (50.8 mm) needle was required to consistently reach the trochanteric bursa. Pain scores were similar at 2 weeks: US: 1.3 ± 1.9 cm; landmark: 2.2 ± 2.5 cm, 95% CI of difference: - 0.7 < 0.9 < 2.5, p = 0.14. At 6 months, US was superior: US: 3.9 ± 2.0 cm; landmark: 5.5 ± 2.6 cm, 95% CI of difference: 0.8 < 1.6 < 2.4, p = 0.036. However, therapeutic duration (US 4.7 ± 1.4 months; landmark 4.1 ± 2.9 months, 95% CI of difference - 2.2 < - 0.6 < 1.0, p = 0.48), and time-to-next intervention (US 8.7 ± 2.9 months; landmark 8.3 ± 3.8 months, 95% CI of difference - 2.8 < - 0.4 < 2.0, p = 0.62) were similar. Costs/patient/year was 43% greater with US (US $297 ± 99, landmark $207 ± 95; p = 0.017). US-guided and anatomic landmark injection of the trochanteric bursa have similar 2-week and 6-month outcomes; however, US guidance is considerably more expensive and less cost-effective. Anatomic landmark-guided injection remains the method of choice, but should be routinely performed using a sufficiently long needle [at least a 2 in (50.8 mm)]. US guidance should be reserved for extreme obesity or injection failure.

An Effective Treatment for Heart Failure Caused by Valvular Heart Diseases: Thoracic Sympathetic Block.

BACKGROUND: The pilot study is designed to investigate the effect of continuous thoracic sympathetic block (TSB) on cardiac function, reconstruction, and hemodynamic parameters in patients with heart failure resulting from valvular heart disease. METHOD: The cardiac function parameters, including left ventricle ejection fraction (LVEF), left ventricle end-diastole diameter (LVEDD), fractional shortening (FS), and N-terminal prohormone of brain natriuretic peptide (NT-proBNP), were measured in 19 patients before and after TSB treatment. The patients were also classified on the basis of NYHA classification system. RESULTS: 4 weeks of TSB administration improved cardiac function in 18 of 19 patients (94.74%). The patients' LVEF, LVEDD, and NT-proBNP were all improved significantly after treatment. CONCLUSIONS: The favorable clinical outcome of TSB administration suggests an alternative treatment for the patients with heart failure caused by valvular dysfunctions.

An Economic Analysis of MAC Versus WALANT: A Trigger Finger Release Surgery Case Study.

BACKGROUND: There has been recent interest in wide awake hand surgery, also referred to as "wide awake local anesthesia with no tourniquet" (WALANT) surgery. Using a model of single trigger finger release (TFR) surgery, a hypothesis was made that WALANT would result in decreased hospital time and cost than patients receiving sedation with monitored anesthetic care (MAC). METHODS: Consecutive cases of single TFR surgery with MAC were compared with WALANT. All surgeries were performed in the same manner, at the same facility, and by the same surgeon. Total operating room (OR) time, surgical time, recovery time, and anesthesia costs were analyzed. RESULTS: There were 78 patients: 31 MAC and 47 WALANT. The MAC group averaged 27.2 minutes of OR time; the WALANT group averaged 25.2 minutes. The MAC group surgical time was 10.2 minutes versus WALANT of 10.4 minutes. Post-operatively, the MAC group averaged 72.3 minutes in the recovery room compared with WALANT group of 30.2 minutes. Each case performed under MAC had a minimum of excess charges from anesthesia of approximately $105. CONCLUSIONS: Patients undergoing single TFR surgery under WALANT trended toward less time in the OR, had similar surgical times, and spent significantly less time in the recovery room, compared with MAC, thereby resulting in less indirect costs. Each MAC case also had minimum direct excess anesthesia charges of $105, which knowingly underestimates overall charges as it excludes material and fixed costs associated with the delivery of anesthesia. Avoiding sedation for high-volume procedures such as TFR may result in significant systemic savings to payers, and in the future with bundling and episode-based payments can become increasingly important to patients, facilities, and surgeons.

Lidocaine/prilocaine spray for premature ejaculation.

Although premature ejaculation is the most common ejaculation problem, it is poorly understood and currently has no standard definition.1 Typically, it involves reduced time to ejaculation, inability to control or delay ejaculation and associated distress.1-5 Treatments that have been assessed include psychosexual counselling, antidepressants (e.g. selective serotonin reuptake inhibitors), phosphodiesterase type-5 inhibitors, tramadol and topical anaesthetic agents (e.g. lidocaine/prilocaine cream). A new formulation (cutaneous spray) of lidocaine/prilocaine (Fortacin-Plethora Solutions Ltd.) was launched in the UK in November 2016 for the treatment of primary premature ejaculation.6,7 Here, we consider the evidence for lidocaine/prilocaine spray and whether it has a role in the treatment of premature ejaculation.

Use of Lidocaine 2% Gel Does Not Reduce Pain during Flexible Cystoscopy and Is Not Cost-Effective.

PURPOSE: To compare the use of lubricant gel with lidocaine versus lubricant gel without anesthetic in flexible cystoscopy in terms of pain and tolerability. MATERIALS AND METHODS: In this observational non-randomized study, 72 patients were divided into two groups. Group 1 included 38 patients in whom lidocaine gel 2% was used and group 2 included 34 patients in whom lubricant gel without anesthetic was administered. The main variables analyzed were score in visual analogue scale (VAS) and score in Spanish Pain Questionnaire (SPQ). Student's t-test and Chi-square test were used to compare differences between 2 groups. The P values < .05% were considered statistically significant. RESULTS: Mean age of patients in group 1 was 64.50 ± 12.39 years and 67.79 ± 10.87 years in group 2 (P = .23). The distribution according to sex was 29 men and 9 women in group 1 and 25 men and 9 women in group 2 (P = .78). The total VAS score was 2.21 ± 2.05 in group 1 versus 1.59 ± 1.61 in group 2 (P = .16). In the SPQ, the current intensity value was 1.82 ± 0.86 in group 1 versus 1.53 ± 0.74 in group 2 (P = .14), and the total intensity value was 1.92 ± 1.86 in group 1 versus 1.03 ± 1.75 in group 2 (P = .04). The cost of gel with lidocaine is 1.25 euro and gel without anesthetic 0.22 euro. CONCLUSION: The use of lidocaine gel does not produce benefit in terms of pain relief in flexible cystoscopy and also is costly.

Efficacy and cost-effectiveness of intradiscal methylene blue injection for chronic discogenic low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Low back pain (LBP) is a common health problem and a substantial part of LBP is presumed to be attributable to degeneration of the intervertebral disc. For patients suffering from intractable discogenic LBP, there are few evidence-based effective interventional treatment options available. In 2010, the results of a randomized controlled trial (RCT) were published concerning "intradiscal methylene blue injection" (IMBI), in which this intervention appeared to be very successful in relieving discogenic pain. Therefore, we decided to repeat this study to investigate whether we could replicate the published results. The results of our preliminary feasibility study gave reason to set up an RCT. The aim of this RCT is to evaluate if IMBI is a more effective treatment of discogenic low back pain as an intradiscal placebo intervention, and furthermore, to assess the cost-effectiveness of this intervention. METHODS/DESIGN: Consecutive discogenic low back pain patients referred to four specialized pain treatment facilities are being screened for eligibility. After a positive standardized provocation discography and informed consent, patients are randomized into two groups. The treatment group receives an intradiscal injection with methylene blue, lidocaine, and contrast, and the control group receives intradiscal isotonic saline with lidocaine and contrast. Main outcome measures are pain at the 6-month follow-up, patient's global impression of change, cost-effectiveness, quality of life, disability, and analgesic intake. DISCUSSION: The importance of this study is emphasized by the fact that for intractable discogenic low back pain patients, evidence-based effective pain treatments are rare. If this study establishes clinical success and cost-effectiveness, IMBI could become the "pain treatment of choice" for a selected group of patients with chronic discogenic low back pain for whom noninvasive treatment options have failed. TRIAL REGISTRATION: National Trial register NTR2547 Registered at 29 September 2010 and 31 March 2014.

Subacromial impingement syndrome and pain: protocol for a randomised controlled trial of exercise and corticosteroid injection (the SUPPORT trial).

BACKGROUND: Subacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults. Management commonly includes exercise and corticosteroid injection. However, the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small, of poor quality, and focus only on short-term results. Exercise packages tend to be standardised rather than individualised and progressed. There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections. However, there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome. This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise (standardised advice and information leaflet versus physiotherapist-led exercise) and from subacromial corticosteroid injection (blind versus ultrasound-guided), and provide long-term follow-up data on clinical and cost-effectiveness. METHODS/DESIGN: The study design is a 2x2 factorial randomised controlled trial. 252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire, UK. Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups: (1) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme, (2) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet, (3) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme, or (4) blind subacromial corticosteroid injection and an advice and exercise leaflet. The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index (SPADI) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions. Although independence of treatment effects is assumed, the magnitude of any interaction effect will be examined (but is not intended for the main analyses). Secondary outcomes will include comparison of long-term outcomes (12 months) and cost-effectiveness. A secondary per protocol analysis will also be performed. DISCUSSION: This protocol paper presents detail of the rationale, design, methods and operational aspects of the SUPPORT trial. TRIAL REGISTRATION: Current controlled trials ISRCTN42399123.

Comparison of tolerance and cost-effectiveness of two nasal anesthesia techniques for transnasal flexible laryngoscopy.

OBJECTIVE: (1) Compare tolerance of aerosolized spray versus syringe administration of topical anesthesia for transnasal flexible laryngoscopy (TFL), (2) analyze cost-effectiveness of both techniques. STUDY DESIGN: Prospective, blinded, randomized trial. SETTING: Tertiary academic laryngology practice. METHODS: One hundred and eight patients underwent TFL over 3 months. Patients were randomized to receive equivalent dose 1:1 neosynephrine/4% plain lidocaine mixture via aerosolized spray ("spray") or application with 1-cc syringe ("syringe"). Patients and physicians independently rated comfort of TFL on 5-point scale (1 = not at all comfortable to 5 = very comfortable). Data were collected on patient and endoscopist experience with TFL and reasons for poor tolerance of laryngoscopy. Cost analyses of disposable spray tips and syringes were calculated. RESULTS: Both patients and physicians reported very high tolerance of TFL. Patient tolerance appears to be similar between spray- versus syringe-administered anesthesia, although study limitations preclude definitive analysis. Poor tolerance of laryngoscopy was reported in 6.5% with comparable distribution between anesthetic delivery methods. There was no impact of patient prior experience with TFL, and there was no difference between anesthetic methods for TFL performed by resident, fellow, or attending. The difference between costs of the disposable spray tip versus syringe was $1.32 per unit. CONCLUSIONS: Use of a 1-cc syringe is an effective method to provide topical nasal anesthesia for TFL and saves $1.32 per unit compared to disposable spray tips. In our practice, transition to syringe-administered nasal anesthesia is projected to save $1300 per 1000 patients, or an anticipated $1000 per year per physician, with excellent patient tolerance of TFL.

Co-phenylcaine Forte spray: innovative ways of minimising cost.

OBJECTIVE: To investigate whether multiple-use Co-phenylcaine Forte® spray was more cost-effective than single-use vials. METHODS: A literature review was conducted to determine the risk of cross-contamination associated with multiple-use topical nasal anaesthetic spray. The costs of multiple-use Co-phenylcaine Forte and single-use co-phenylcaine were compared, and potential savings were calculated. The cost of procuring these drugs from other sources was also examined. RESULTS: Switching to multiple-use Co-phenylcaine Forte spray would lead to at least 40 per cent savings if bought from our local retailer. Potential savings of more than 70 per cent could be made if the drugs were procured from sources other than our local distributor. CONCLUSION: Multiple-use Co-phenylcaine Forte spray is safe to use and more cost-effective than single-use vials. This paper illustrates how money can be saved within the National Health Service through changes in drug procurement. Similar cost savings to those calculated for our department could be made in other ENT departments nationally, depending on their annual consumption of co-phenylcaine.

A randomized double-blind study comparing intradermal anesthetic tolerability, efficacy, and cost-effectiveness of lidocaine, buffered lidocaine, and bacteriostatic normal saline for peripheral intravenous insertion.

In this double-blind study, 256 surgical patients meeting eligibility criteria were randomized in a 1:1:1 ratio to 1 of the 3 intradermal injection groups prior to intravenous (IV) line insertion (Group 1=1% lidocaine, Group 2=1% buffered lidocaine, and Group 3=bacteriostatic normal saline with a benzyl alcohol preservative). The most tolerable solution, as measured by the average level of pain from an intradermal insertion, was buffered lidocaine (Group 2). The most efficacious, as measured by average level of pain at IV cannulation, were Groups 1 and 2. Group 3 was the most cost-effective.

The prevalence and cost of unapproved uses of top-selling orphan drugs.

INTRODUCTION: The Orphan Drug Act encourages drug development for rare conditions. However, some orphan drugs become top sellers for unclear reasons. We sought to evaluate the extent and cost of approved and unapproved uses of orphan drugs with the highest unit sales. METHODS: We assessed prescription patterns for four top-selling orphan drugs: lidocaine patch (Lidoderm) approved for post-herpetic neuralgia, modafinil (Provigil) approved for narcolepsy, cinacalcet (Sensipar) approved for hypercalcemia of parathyroid carcinoma, and imatinib (Gleevec) approved for chronic myelogenous leukemia and gastrointestinal stromal tumor. We pooled patient-specific diagnosis and prescription data from two large US state pharmaceutical benefit programs for the elderly. We analyzed the number of new and total patients using each drug and patterns of reimbursement for approved and unapproved uses. For lidocaine patch, we subcategorized approved prescriptions into two subtypes of unapproved uses: neuropathic pain, for which some evidence of efficacy exists, and non-neuropathic pain. RESULTS: We found that prescriptions for lidocaine patch, modafinil, and cinacalcet associated with non-orphan diagnoses rose at substantially higher rates (average monthly increases in number of patients of 14.6, 1.45, and 1.58) than prescriptions associated with their orphan diagnoses (3.12, 0.24, and 0.03, respectively (p<0.001 for all)). By contrast, for imatinib, approved uses increased significantly over off-label (0.97 vs. 0.47 patients, p<0.001). Spending on off-label uses was highest for lidocaine patch and modafinil (>75%). Increases in lidocaine patch use for non-neuropathic pain far exceeded neuropathic pain (10.2 vs. 3.6 patients, p<0.001). DISCUSSION: In our sample, three of four top-selling orphan drugs were used more commonly for non-orphan indications. These orphan drugs treated common clinical symptoms (pain and fatigue) or laboratory abnormalities. We should continue to monitor orphan drug use after approval to identify products that come to be widely used for non-FDA approved indications, particularly those without adequate evidence of efficacy.

Comparison of topical anesthetics for intravitreal injections : a randomized clinical trial.

PURPOSE: To determine whether there is a difference in anesthetic effect between topical proparacaine drops, 4% lidocaine solution, or 3.5% lidocaine gel, and whether this has an impact on the overall injection experience. METHODS: One hundred and twenty sequential patients undergoing intravitreal injections were randomized to 1 of 3 groups: proparacaine 0.5% drops (Group 1), proparacaine + 4% lidocaine-soaked cotton tipped swabs (Group 2), or 3.5% lidocaine gel (Group 3). Discomfort associated with the lid speculum, with the needle, and with burning sensation was graded on a scale of 0 to 10 (0 = no pain, 10 = worst pain ever). The overall injection experience was graded as Excellent, Very Good, Fair, Poor, or Awful. RESULTS: The average lid speculum pain score for Group 1 was 0.85, Group 2 was 0.50, and Group 3 was 0.65 (P = 0.32). The average needle pain score for Group 1 was 1.78, Group 2 was 1.75, and Group 3 was 1.48 (P = 0.38). The average burning pain score for Group 1 was 1.45, Group 2 was 1.58, and Group 3 was 1.13 (P = 0.23). Overall satisfaction was rated as Excellent or Very Good in 95%, 97.5%, and 92.5% of Group 1, 2, and 3 patients, respectively (P = 0.64). CONCLUSION: The use of topical proparacaine drops provides very effective and cost-effective anesthesia during office-based intravitreal injections.

Effects of lidocaine infiltration on cost of rhinoplasty made under general anesthesia.

This study aimed to compare the effects of combined and noncombined lidocaine with adrenaline infiltration in general anesthesia (GA) procedures, in which the standard anesthesia depth is monitored by Bispectral Index monitoring, on minimum alveolar concentration (MAC) levels and the costs. Following approval by the local ethics committee, an American Society of Anesthesiologists physical status I­II group of 40 adult patients for whom elective rhinoplasties under GA were planned was divided into 2 double-blind randomized groups. In group 1, GA and lidocaine + adrenaline were administered, whereas in group 2, only GA and adrenaline were administered. All the patients who had been taken to the operation room underwent electrocardiography and measurements of the peripheral oxygen saturation, end-tidal carbon dioxide, heart rate, mean blood pressure, and Bispectral Index monitoring. Using the operation time and the MAC% values, the total consumed inhalation agent amounts were calculated, and the cost difference was determined. The mean blood pressure values were lower in group 1 (P < 0.05). In group 1, the MAC% was 20.83% lower than that of group 2; the consumed desflurane amount was 20.29%, and the cost was 20.29% lower than that of group 2 (P < 0.05). In rhinoplasties under GA, the lidocaine + adrenaline combination infiltration not only decreased inhaled anesthetic requirement and cost but also supported the hemodynamic stability. In addition, surgical satisfaction increased in the lidocaine + adrenaline group because of small number of agitated patients during the recovery period.