Controlled, non-inferiority trial of bupivacaine liposome injectable suspension

2019 ◽  
Vol 22 (10) ◽  
pp. 916-921
Author(s):  
Wanda J Gordon-Evans ◽  
Hanah Y Suh ◽  
Alonso G Guedes

Objectives Recently, a bupivacaine liposome injectable suspension (BLIS) became commercially available in the veterinary market that may provide local analgesia for 72 h. The purpose of this study was to compare a BLIS incisional block with a control protocol in cats after ovariohysterectomy (OHE). The hypothesis was that a BLIS block would provide equivalent pain relief. Methods This study was designed as a randomized, double-blind, non-inferiority trial. Students performed an OHE followed by a two-layer incisional and body wall block with either standard bupivacaine (control) or BLIS. Postoperatively, cats in the control group received robenacoxib, whereas the BLIS cats received saline. All cats were evaluated using the feline Glasgow Composite Measure Pain Scale (GCMPS) at multiple time points postoperatively. Results There were 24 control cats and 23 BLIS cats. One cat from each group required rescue medication. The mean GCMPS scores were low and the groups were equivalent at all time points ( P <0.05). This study showed that BLIS was equivalent to the control group up to 42 h and pain scores remained low up to 68 h after surgery. Conclusions and relevance BLIS incisional block is equivalent to a control pain protocol and reduces the need for continued postoperative drug administration.

1991 ◽  
Vol 19 (4) ◽  
pp. 551-554 ◽  
Author(s):  
A. McCrirrick ◽  
D. T. O. Ramage

The efficacy of a single caudal epidural injection of bupivacaine 20 ml 0.5% following emergency orthopaedic surgery to the lower leg and ankle was investigated. Forty adult patients were studied, randomised to either the caudal or control group. The mean 24 hour postoperative papaveretum consumption was significantly reduced in the caudal group. Analogue pain scores as assessed in a double-blind manner were also significantly reduced in this group. The duration of analgesia after caudal blockade was approximately eight hours as estimated by the average time to the first dose of papaveretum. Our study demonstrates that caudal blockade represents an effective adjunct to intramuscular opiates following this type of surgery.


CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S42-S43
Author(s):  
M. Desjardins ◽  
S. Gouin ◽  
N. Gaucher ◽  
D. Lebel ◽  
J. Gravel

Introduction: Oral sweet solutions have been accepted as effective analgesics for procedures in the neonatal population. However, there have been a limited number of trials in older infants. These studies have conflicting results. The objective of the study was to compare the efficacy of an oral sucrose solution versus placebo in reducing pain during urethral catheterization in infants 1 to 3 months old in the Emergency Department (ED). Methods: A randomized, double-blind clinical trial was conducted in a pediatric university-affiliated hospital ED. Infants, 1 to 3 months of age, were recruited and randomly allocated to receive 2 ml of 88% sucrose solution (SUC) or 2 ml of placebo solution (PLA) orally, 2 minutes before planned urethral catheterization. The primary outcome measure was the difference in pain scores as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale at 1 min post procedure. Secondary outcome measures were the difference in pain scores using the Neonatal Infant Pain Scale (NIPS), crying time and variations in heart rate. Results: Seventy-six participants were recruited and completed the study, 37 (group SUC) and 39 (group PLA) respectively. The mean difference in FLACC scores compared to baseline was 5.62 ± 1.32 (SUC) vs. 6.21 ± 1.15 (PLA) (p=.51) during catheterization, 2.70 ± 1.21 (SUC) vs. 2.26 ± 1.41 (PLA) at 1 min (p=.64) and 0.66 ± 1.32 (SUC) vs. 1.26 ± 1.00 (PLA) at 3 mins (p=.38). For the NIPS scores, it was 4.27 ± 1.06 (SUC) vs. 4.69 ± 0.92 (PLA) (p=.56) during procedure, 2.05 ± 0.91 (SUC) vs. 1.97 ± 1.19 (PLA) (p=.92) at 1 min and 0.49 ± 0.89 (SUC) vs. 0.89 ± 0.97 (PLA) (p=.54) at 3 mins. The difference in the mean crying time was not different between both groups: 99 ± 34 secs (SUC) vs. 100 ± 25 (PLA) (p=.99). No significant difference was found in participants’ heart rate variations during procedure 23 ± 8 BPM (SUC) vs. 26 ± 7 (PLA) (p=.60), after 1 min 19 ± 12 BPM (SUC) vs. 17 ± 7 (PLA) (p=.76) and after 3 mins -1 ± 12 BPM (SUC) vs. 3 ± 6 (PLA) (p=.53). Conclusion: In infants 1 to 3 months of age undergoing urethral catheterization in the ED, administration of an oral sweet solution did not statistically decrease pain scores as measured by the FLACC and NIPS scales. Participants’ heart rate variations and crying time were not significantly decreased when sucrose was provided.


2020 ◽  
Vol 48 ◽  
Author(s):  
Fabiana Del Lama Rocha ◽  
Newton Nunes ◽  
Paula Chiconi Dacunto dos Santos ◽  
Cléber Kazuo Ido ◽  
Paloma Do Espírito Santo Silva ◽  
...  

Background: Mastectomy, a procedure with high pain stimulation, is the treatment of choice for bitches with breast cancer. Tumescent anaesthesia is widely used for transoperative and postoperative analgesia in bitches submitted to mastectomy, because facilitates tissue divulsion, also contributing significantly for the rapid recovery of patients. Although, there is no consensus as to which local anesthetic to use and at what concentration it should be used. Herein was investigated which local anesthetics, lidocaine or ropivacaine, when used in tumescent solutions, could provide a more lasting analgesic effect in the postoperative period in bitches submitted to radical unilateral mastectomy.Materials, Methods & Results: Sixteen bitches were sedated with chlorpromazine (0.3 mg/kg) and meperidine (3 mg/kg) followed by anesthesia with propofol and isofluorane. Then, bitches were randomly assigned to two groups (n= 8 each): LG group, infused with 15 mL/kg of tumescence solution containing 0.1% lidocaine; and RG group, infused with 15 mL/kg of tumescence solution with 0.1% ropivacaine. The study was conducted in a double-blind fashion. Control group did not include, because the patients would be submitted to severe or unbearable pain, according to the short-form of the Glasgow pain Scale (CMPS-SF). The heart (HR) and respiratory (ƒ) rates, and systolic blood pressure (SBP) were measured in the pre-operative period and immediately after extubation (Mextub) and at 0.5 h, 1 h, 2 h, 4 h, 8 h, and 12 h after the extubation. Analgesic efficacy was assessed using the CMPS-SF and von Frey filaments. Both groups showed higher means for HR at 0.5 h (167 ± 7 in LG; 170 ± 7 in RG) than at 4 h (117 ± 7 in LG; 120 ± 7 in RG). CMPS-SF revealed higher medians (P= 0.038) at the Mextub and 12 h time points for the LG [5 (3-6) and 1 (0-2)] than for the RG [5 (2-5) and 0 (0-1)].Discussion: Pain was excluded as a possible explanation for the difference presented for HR in both groups because, moderate pain is considered when more than two cardiorespiratory parameters show an increase of at least 20% in relation to baseline values, which did not occur in this study. Indeed, most animals were walking at 0.5 h after extubation and, in many cases, this occurred before the collection of data for the postoperative period. This may have influenced the results since exercise releases catecholamines and increases HR. Moreover at 4 h after extubation, most animals were asleep. As metabolism decreases during sleep, expected that HR would also decrease and that was indeed the case. Regarding CMPS-SF, the way the patients walks was the item that most contributed to the high score found for the Mextub time point because it's impossible to be performed seconds after extubation. As the reluctance to move occurred only immediately after extubation, the values obtained at the Mextub time point are more likely to be due to an anesthetic residual effect and not to the pain stimulus itself. When the groups were compared, the median values obtained at the LG were greater than RG at the Mextub and 12 h postoperative time points.  There was no need for analgesic rescue differing from those in literature that reported the need for analgesic rescue in 50% of the animals. Those study established a CMPS-SF score of 3.3 as indicative for analgesic rescue whereas our research established a score of 7. Tumescence solutions with lidocaine or ropivacaine provide equivalent postoperative analgesia for at least 12 h.


2020 ◽  
pp. jramc-2019-001261
Author(s):  
Alastair Beaven ◽  
E Sellon ◽  
M Ballard ◽  
P Parker

IntroductionThere is a need for a military tourniquet to control catastrophic haemorrhage in a chemical, biological, radiological or nuclear (CBRN) threat environment. No published data exist as to the efficacy of tourniquets while wearing British military CBRN individual protective equipment (IPE).Methods12 volunteers from the counter CBRN instructors’ course allowed testing on 24 legs. A Combat Application Tourniquet (C-A-T) was applied to all volunteers at the level of the midthigh. 12 legs were tested while wearing CBRN IPE (both operator and simulated casualty), and the control group of 12 legs was tested while wearing conventional combat dress state (both operator and simulated casualty). The order of leg laterality and dress state were sequenced according to a prerandomised system. Efficacy was measured via use of an ultrasound probe at the popliteal artery. Tourniquets were considered effective if arterial flow was completely occluded on ultrasound imaging. Data were collected on time to successful application, failure of tourniquets and pain scores as rated by the visual analogue scale (1–10).ResultsThere were no failures of tourniquet application in the CBRN group, and two failures (17%) in the control group. Failures were pain threshold exceeded (n=1) and tourniquet internal strap failure (n=1). The mean application time for the CBRN group was 28.5 s (SD 11.7) and 23.7 s (SD 9.8) for the conventional combat group. There was no statistically significant difference (p=0.27). The median CBRN pain score was 2.0 (IQR 2.0–3.5). The median control pain score was 4.0 (IQR 3–6). This was a statistically significant difference (p=0.002).ConclusionC-A-Ts applied to simulated casualties in CBRN IPE at the midthigh are at least as efficacious as those applied to the midthigh in a conventional combat dress state. The pain experienced was less in CBRN IPE than when in a conventional combat dress state.


2021 ◽  
Vol 13 (15) ◽  
pp. 3042
Author(s):  
Kateřina Gdulová ◽  
Jana Marešová ◽  
Vojtěch Barták ◽  
Marta Szostak ◽  
Jaroslav Červenka ◽  
...  

The availability of global digital elevation models (DEMs) from multiple time points allows their combination for analysing vegetation changes. The combination of models (e.g., SRTM and TanDEM-X) can contain errors, which can, due to their synergistic effects, yield incorrect results. We used a high-resolution LiDAR-derived digital surface model (DSM) to evaluate the accuracy of canopy height estimates of the aforementioned global DEMs. In addition, we subtracted SRTM and TanDEM-X data at 90 and 30 m resolutions, respectively, to detect deforestation caused by bark beetle disturbance and evaluated the associations of their difference with terrain characteristics. The study areas covered three Central European mountain ranges and their surrounding areas: Bohemian Forest, Erzgebirge, and Giant Mountains. We found that vertical bias of SRTM and TanDEM-X, relative to the canopy height, is similar with negative values of up to −2.5 m and LE90s below 7.8 m in non-forest areas. In forests, the vertical bias of SRTM and TanDEM-X ranged from −0.5 to 4.1 m and LE90s from 7.2 to 11.0 m, respectively. The height differences between SRTM and TanDEM-X show moderate dependence on the slope and its orientation. LE90s for TDX-SRTM differences tended to be smaller for east-facing than for west-facing slopes, and varied, with aspect, by up to 1.5 m in non-forest areas and 3 m in forests, respectively. Finally, subtracting SRTM and NASA DEMs from TanDEM-X and Copernicus DEMs, respectively, successfully identified large areas of deforestation caused by hurricane Kyril in 2007 and a subsequent bark beetle disturbance in the Bohemian Forest. However, local errors in TanDEM-X, associated mainly with forest-covered west-facing slopes, resulted in erroneous identification of deforestation. Therefore, caution is needed when combining SRTM and TanDEM-X data in multitemporal studies in a mountain environment. Still, we can conclude that SRTM and TanDEM-X data represent suitable near global sources for the identification of deforestation in the period between the time points of their acquisition.


2012 ◽  
Vol 9 (5) ◽  
pp. 610-620 ◽  
Author(s):  
Thomas A Trikalinos ◽  
Ingram Olkin

Background Many comparative studies report results at multiple time points. Such data are correlated because they pertain to the same patients, but are typically meta-analyzed as separate quantitative syntheses at each time point, ignoring the correlations between time points. Purpose To develop a meta-analytic approach that estimates treatment effects at successive time points and takes account of the stochastic dependencies of those effects. Methods We present both fixed and random effects methods for multivariate meta-analysis of effect sizes reported at multiple time points. We provide formulas for calculating the covariance (and correlations) of the effect sizes at successive time points for four common metrics (log odds ratio, log risk ratio, risk difference, and arcsine difference) based on data reported in the primary studies. We work through an example of a meta-analysis of 17 randomized trials of radiotherapy and chemotherapy versus radiotherapy alone for the postoperative treatment of patients with malignant gliomas, where in each trial survival is assessed at 6, 12, 18, and 24 months post randomization. We also provide software code for the main analyses described in the article. Results We discuss the estimation of fixed and random effects models and explore five options for the structure of the covariance matrix of the random effects. In the example, we compare separate (univariate) meta-analyses at each of the four time points with joint analyses across all four time points using the proposed methods. Although results of univariate and multivariate analyses are generally similar in the example, there are small differences in the magnitude of the effect sizes and the corresponding standard errors. We also discuss conditional multivariate analyses where one compares treatment effects at later time points given observed data at earlier time points. Limitations Simulation and empirical studies are needed to clarify the gains of multivariate analyses compared with separate meta-analyses under a variety of conditions. Conclusions Data reported at multiple time points are multivariate in nature and are efficiently analyzed using multivariate methods. The latter are an attractive alternative or complement to performing separate meta-analyses.


Author(s):  
Maryam Sadeghi ◽  
Naeimeh Moheb ◽  
Marziyeh Alivandi Vafa

Introduction: The aim of current paper was to compare the effectiveness of acceptance and commitment group therapy (ACT) and group cognitive therapy (GCT) on Alexithymia and marital boredom (MB) among women affected by marital infidelity in Mashhad. Method: This clinical trial was a double- blind study with a pretest-posttest design in which two intervention groups and one control group were investigated. The study performed on women who realized their spouse infidelity and referred to Azad University Counseling Center in Mashhad in 2018. The sample consisted of 30 women who were selected by purposive sampling and were randomly assigned to two intervention groups and a control group (n=10 per group). The intervention groups were put under ACT training (twelve 90-minute sessions) and GCT training (twelve 90-minute sessions), but the control group did not receive any intervention. Data was obtained by the Toronto Alexithymia Scale-20 and Pines Marital Boredom Scale and was analyzed by multivariate analysis of covariance with SPSS (version 22) software. Results: The results showed a significant reduction in the mean score of MB in the ACT group, also there was a significant reduction in the mean score of Alexithymia in the GCT group (P <0.05). So comparing both therapies, ACT was more influential on reducing marital boredom whereas GCT was more effective on reducing alexithymia. Conclusion: Although both intervention methods were effective on Alexithymia and Marital Boredom in women affected by marital infidelity, it was demonstrated that ACT and GCT have more effect on Marital Boredom and Alexithymia, respectively.


2019 ◽  
Vol 4 (3) ◽  
pp. 1-6
Author(s):  
Farzin Sahebjam

Background : To compare the duration of action of a local anesthetic block using a lipid formulation of bupivacaine to the commercially available aqueous formulation. Bupivacaine 0.5% was mixed with an equal volume of either lipid emulsion (Intralipid, Fresenius Kabi) or normal saline resulting in a final concentration of 0.25% bupivacaine. Eighteen sheep were administered a n erve block of either control or treatment at the metacarpal region of each forelimb to compare the efficacy of the injected formulations. The nociceptive test was determined by applying a blunt noxious stimulus to the foot below the nerve block at multiple time intervals until the sheep responded by withdrawing its foot. The person assessing the response to the noxious stimulus was blinded to the treatment. Results: The Intralipid formulation significantly extended the duration of the nerve block compared to the control group. The mean analgesic period (mean±SD) in the control legs was 4.23±1.8 hr. compared to 5.81±1.78 hr. in the Intralipid injected legs (p=0.013). Conclusions : In conclusion, an Intralipid® - based formulation provided a more prolonged dura tion of local anesthesia after nerve blocks in the sheep metacarpal region compared to aqueous bupivacaine.


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