scholarly journals 1039 Assessing the Efficacy of The Modified S-PECS Anaesthetic Block in Patients Undergoing Breast Augmentation Surgery – A Randomised Double-Blind Control Trial

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
R Saghir ◽  
N Saghir ◽  
R Okhiria ◽  
T Okhiria ◽  
M Sidhu ◽  
...  
Keyword(s):  
Breast Augmentation ◽  
Breast Implants ◽  
Local Anaesthetics ◽  
Control Group ◽  
Serratus Anterior ◽  
Double Blind ◽  
Pain Medications ◽  
Pectoral Nerve ◽  
Anaesthetic Block ◽  
Randomised Controlled

Abstract Aim Postoperative acute on chronic pain following breast surgery is a common complication which needs resolving to allow for improved patient outcomes. Previously thoracic epidurals and paravertebral blocks (PVB) have been the gold standard administered intra-operatively. However, more recently the introduction of the Pectoral nerve block (PECS and PECS-2 blocks) has looked promising to control the pain more effectively, but further robust analysis is required to prove its efficacy. The authors aim to study the efficacy of a new block S-PECS that comprises a serratus anterior and a PECS-2 block associated. Method In this study we performed a prospective, single-centre randomised controlled double-blind group trial in 30 female patients undergoing breast augmentation surgery with silicone breast implants and the S-PECS block. Divided into groups of 15, the S-PECS group received local anaesthetics with the no-PECS control group receiving a saline injection. All participants were followed up at recovery (REC), 4, 6 and 12 (4H, 6H and 12H) hourly postoperatively. Results Our results showed that the pain score in the S-PECS group was significantly less than the no-PECS group across all time points REC, 4H, 6H and 12H. Furthermore, the patients that received the S-PECS block were 74% less likely to request pain medications compared to the no-PECS group (p < 0.05). Conclusions Overall, the modified S-PECS block is an effective, efficient, and safe method of controlling pain in patients undergoing breast augmentation surgery with additional applications yet to be explored.

EP.TH.111Assessing the efficacy of the modified S-PECS anaesthetic block in patients undergoing breast augmentation surgery – a randomised double-blind control trial

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Noman Saghir ◽  
Reyan Saghir ◽  
Manu Sidhu ◽  
Terrell Okhiria ◽  
Renee Okhiria ◽  
...  
Keyword(s):  
Breast Augmentation ◽  
Breast Implants ◽  
Local Anaesthetics ◽  
Control Group ◽  
Serratus Anterior ◽  
Double Blind ◽  
Pain Medications ◽  
Pectoral Nerve ◽  
Anaesthetic Block ◽  
Randomised Controlled

Abstract Aim Postoperative acute chronic pain following breast surgery is a common complication which needs resolving to allow for improved patient outcomes. Previously thoracic epidurals and paravertebral blocks (PVB) have been the gold standard administered intra-operatively. However, more recently the introduction of the Pectoral nerve block (PECS and PECS-2 blocks) has looked promising to control the pain more effectively, but further robust analysis is required to prove its efficacy. The authors aim to study the efficacy of a new block S-PECS that comprises a serratus anterior and a PECS-2 block associated. Methods In this study we performed a prospective, single-centre randomised controlled double-blind group trial in 30 female patients undergoing breast augmentation surgery with silicone breast implants and the S-PECS block. Divided into groups of 15, the S-PECS group received local anaesthetics with the no-PECS control group receiving a saline injection. All participants were followed up at recovery (REC), 4, 6 and 12 (4H, 6H and 12H) hourly postoperatively. Results Our results showed that the pain score in the S-PECS group was significantly less than the no-PECS group across all time points REC, 4H, 6H and 12H. Furthermore, the patients that received the S-PECS block were 74% less likely to request pain medications compared to the no-PECS group (p < 0.05). Conclusion Overall, the modified S-PECS block is an effective, efficient and safe method of controlling pain in patients undergoing breast augmentation surgery with additional applications yet to be explored.

scholarly journals Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Cardiovascular Outcomes ◽  
Control Group ◽  
Type I ◽  
Dialysis Patients ◽  
Double Blind ◽  
Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

Efficacy and safety of prophylaxis with once-weekly BAY 79–4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients

2012 ◽  
Vol 108 (11) ◽  
pp. 913-922 ◽  
Author(s):  
Uri Martinowitz ◽  
Jerzy Windyga ◽  
Giovanni Di Minno ◽  
Andrzej Hellmann ◽  
Ingrid Pabinger ◽  
...  
Keyword(s):  
Controlled Study ◽  
Control Group ◽  
Investigational Drug ◽  
Haemophilia A ◽  
Double Blind ◽  
Investigational Treatment ◽  
Joint Health ◽  
Secondary Endpoints ◽  
Recombinant Fviii ◽  
Randomised Controlled

SummaryThe benefits of prophylaxis of haemophilia A patients regarding joint health and quality-of-life are well established. However, adherence to an up to every-other-day infusion regimen is a barrier to widespread adoption of prophylaxis. BAY 79–4980 is an investigational drug consisting of rFVIII-FS (sucrose-formulated recombinant FVIII) reconstituted with liposome solvent. Previous clinical studies showed extended protection from bleeding after a single injection of BAY 79–4980 (13.3 ± 6.2 days) compared with rFVIII-FS (7.2 ± 1.7 days). The effect of once-a-week prophylaxis with BAY 79–4980 (35 IU/kg) compared with three times-per-week rFVIII-FS (25 IU/kg) in previously treated, severe haemophilia A patients was evaluated in a 52-week, double-blind, two-arm, randomised, controlled study. The primary and secondary endpoints were protection from total bleeds and joint bleeds, respectively. Short- and long-term safety and tolerability of BAY 79–4980 including effects on lipid levels were assessed. A total of 139 and 131 subjects were evaluable for safety and efficacy analyses, respectively. A large difference in efficacy between treatment groups was observed with 72.1% (49/68) in the rFVIII-FS control group demonstrating <9 bleeds/year compared with 38.1% (24/63) of BAY 79–4980-treated subjects. A similar difference was seen in annualised joint bleeds, with 43 subjects (63.2%) in the control group demonstrating <5 joint bleeds/year compared with 24 subjects (38.1%) treated with BAY 79–4980. The distribution of bleeds seven days post-prophylactic treatment with BAY 79–4980 showed that 61% of bleeds occurred after day 4 post dosing. There were no safety concerns identified. The investigational treatment arm was prematurely discontinued due to failure to achieve the primary endpoint.

Pre-emptive triple analgesia protocol for tonsillectomy pain control in children: double-blind, randomised, controlled, clinical trial

2013 ◽  
Vol 127 (4) ◽  
pp. 383-391 ◽  
Author(s):  
A M A El-Fattah ◽  
E Ramzy
Keyword(s):  
Postoperative Pain ◽  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Post Surgery ◽  
Scale Scores ◽  
Randomised Controlled ◽  
At Home

AbstractIntroduction:This double-blind, controlled, parallel-group study was designed to determine the efficacy of pre-emptive triple analgesia for paediatric post-tonsillectomy pain management.Materials and methods:One hundred and thirty-five children were randomised into two groups: pre-emptive triple analgesia (n = 55) and control (n = 80). Pain was assessed using a visual analogue scale (in hospital) and the Parent's Postoperative Pain Measure (at home), and scores recorded.Results:Visual analogue scale scores on awakening and for 6 hours post-surgery were significantly better in the study group than the control group (p < 0.05). The Parent's Postoperative Pain Measure scores of control group children were significantly higher within the first 3 post-operative days (p = 0.000), with a greater percentage of children experiencing significant pain and requiring more analgesia.Conclusion:The proposed multimodal, pre-emptive analgesia protocol for paediatric post-tonsillectomy pain results in less post-operative pain, both in hospital or at home.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

Low-Dose Dexamethasone as an Adjuvant for Prolonging the Duration of Brachial Plexus Block with Bupivacaine—a Prospective Randomised Controlled Study

2021 ◽  
Author(s):  
Seetharaman Hariharan
Keyword(s):  
Brachial Plexus ◽  
Low Dose ◽  
Controlled Trial ◽  
Demographic Data ◽  
Local Anaesthetics ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Dexamethasone Group ◽  
Duration Of Surgery

Objectives Dexamethasone, in the dose of 8 mg or higher, has been advocated to be used as an adjuvant to prolong the duration of brachial plexus blocks with local anaesthetics. This study aimed to test the hypothesis that a lower dose of dexamethasone (4 mg) added to bupivacaine would prolong the duration of analgesia in brachial plexus blocks. Methods A randomized double-blind placebo-controlled trial was conducted on patients who underwent supraclavicular brachial plexus blocks using an ultrasound. Patients were randomized to receive 19 mL of 0.5% bupivacaine with dexamethasone (4 mg) (study group) and saline (1 mL) (control group). Primary outcome measure was the duration of analgesia. Onset and duration of sensory, motor blocks, postoperative 24-hour morphine requirements were also recorded. Results A total of 46 patients were studied with 24 patients in the dexamethasone group and 22 patients in the control group. Demographic data, type and duration of surgery were comparable between the groups. Dexamethasone group patients had significantly longer duration of analgesia [Mean (SD): 19.8 (3.8) hours], compared to control group patients [Mean (SD): 14.5 (4.2); p< 0.001]. Morphine requirements over a 24-hour period were not significantly different between the groups. Conclusion Low-dose dexamethasone significantly prolongs the duration of analgesia when used with bupivacaine in supraclavicular brachial plexus blocks, although it does not significantly decrease the overall opioid requirements for 24 hours postoperatively.

scholarly journals The effect of zinc supplementation on pregnancy outcomes: a double-blind, randomised controlled trial, Egypt

2015 ◽  
Vol 114 (2) ◽  
pp. 274-285 ◽  
Author(s):  
Samia A. Nossier ◽  
Noha E. Naeim ◽  
Nawal A. El-Sayed ◽  
Azza A. Abu Zeid
Keyword(s):  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Neonatal Morbidity ◽  
Control Group ◽  
Double Blind ◽  
Serum Zn ◽  
Randomised Controlled ◽  
Low Serum

The present randomised controlled trial (RCT) was conducted to evaluate the effect of two regimens of Zn supplementation on pregnancy outcomes in Alexandria, Egypt. Healthy pregnant women aged 20–45 years and having low serum Zn level below the estimated median for the gestational age were eligible to participate in the trial. Of 1055 pregnant women assessed for the eligibility of low serum Zn level, 675 were eligible. These women were randomly assigned to one of the three groups: the Zn alone group (n 225) received a daily dose of 30 mg ZnSO4, the combined group (n 227) received 30 mg ZnSO4 plus multivitamins (B1, B6, D3, C and E) and the control group (n 223) received placebo (270 mg lactose). They were followed up from the time of recruitment till 1 week after delivery. Overall, there was no detectable difference in the mean birth weight between the three groups (mean 2929·12 (sd 330·28), 2922·22 (sd 324·05) and 2938·48 (sd 317·39) g for the placebo, Zn and Zn plus multivitamin groups, respectively, P= 0·88). Both the single and the combined Zn supplements were almost equally effective in reducing second- and third-stage complications (relative risk (RR) 0·43, 95 % CI 0·31, 0·60 for the Zn group and RR 0·54, 95 % CI 0·40, 0·73 for the combined group). Stillbirth and preterm delivery were significantly lower among the two supplemented groups than the placebo group (P= 0·001). Early neonatal morbidity was also significantly lower in the supplemented groups (RR 0·23, 95 % CI 0·15, 0·35 for the Zn group and RR 0·25, 95 % CI 0·16, 0·37 for the combined group). Collectively, Zn supplementation was effective in reducing pregnancy complications and early neonatal infection among the Zn-deficient women of the present trial.

scholarly journals Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study

2016 ◽  
Vol 5 ◽  
Author(s):  
M. Abrahamse-Berkeveld ◽  
M. Alles ◽  
E. Franke-Beckmann ◽  
K. Helm ◽  
R. Knecht ◽  
...  
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Blood Parameters ◽  
Daily Weight Gain ◽  
Control Group ◽  
Double Blind ◽  
Term Infants ◽  
Bifidobacterium Breve ◽  
Randomised Controlled ◽  
Hydrolysed Formula

AbstractThe objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome. In a randomised, controlled, double-blind, multicentre, intervention study infants were assigned to an extensively hydrolysed formula containing a specific combination of Bifidobacterium breve M-16V and a prebiotic mixture (short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides in a 9:1 ratio; scGOS/lcFOS; synbiotic group), or the same formula without this synbiotic concept for 13 weeks (control group). Anthropometry, formula intake, tolerance, stool characteristics, blood parameters, faecal microbiota and metabolic faecal profile were assessed. Medically confirmed adverse events were recorded throughout the study. Equivalence in daily weight gain was demonstrated for the intention-to-treat (ITT) population (n 211). In the per-protocol (PP) population (n 102), the 90 % CI of the difference in daily weight gain slightly crossed the lower equivalence margin. During the intervention period, the mean weight-for-age and length-for-age values were close to the median of the WHO growth standards in both groups, indicating adequate growth. The number of adverse events was not different between both groups. No relevant differences were observed in blood parameters indicative for liver and renal function. At 13 weeks, an increased percentage of faecal bifidobacteria (60 v. 48 %) and a reduced percentage of Clostridium lituseburense/C. histolyticum (0·2 v. 2·6 %) were observed in the synbiotic group (n 19) compared with the control group (n 27). In conclusion, this study demonstrates that an extensively hydrolysed formula with B. breve M-16V and the prebiotic mixture scGOS/lcFOS (9:1) supports an adequate infant growth.

scholarly journals An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial

2011 ◽  
Vol 107 (11) ◽  
pp. 1616-1622 ◽  
Author(s):  
Jean-Christophe Rozé ◽  
Sébastien Barbarot ◽  
Marie-José Butel ◽  
Nathalie Kapel ◽  
Anne-Judith Waligora-Dupriet ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Infant Formula ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Secretory Iga ◽  
Control Group ◽  
Double Blind ◽  
Randomised Controlled ◽  
Similar Growth ◽  
Experimental Group

The aim of the present study was to evaluate the safety, tolerance and preventive effect on atopic dermatitis of an experimental α-lactalbumin-enriched and symbiotic-supplemented infant formula. A total of ninety-seven non-breastfed term neonates were enrolled into a double-blind, multicentre, randomised controlled trial in which they received experimental (n 48) or standard formula (n 49) for 6 months. The primary outcome was weight at 6 months of age. Secondary outcomes were gastrointestinal tolerance and manifestation of atopic dermatitis. Faecal secretory IgA (SIgA) concentration and microbiota composition of forty-three infants were analysed at 1 and 6 months. Growth was similar in both groups. At 1 month, compared to those in the control group, infants in the experimental group exhibited less crying or agitation, and more quiet behaviour (P = 0·03). At 6 months, atopic dermatitis was less frequently observed in the experimental group (P < 0·05). Decrease of faecal SIgA concentration between 1 and 6 months was mainly observed in the control group. This decrease was significantly associated with atopic dermatitis (P < 0·014) and negatively correlated to the level of colonisation by bifidobacteria (P < 0·005). In conclusion, compared to the control formula, the experimental formula guaranteed a similar growth, was better tolerated at 1 month and had a protective effect against the development of atopic dermatitis.

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