A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery

Anaesthesia ◽  
2021 ◽  
Author(s):  
A. J. Toner ◽  
M. A. Bailey ◽  
S. A. Schug ◽  
T. B. Corcoran
The Breast ◽  
1997 ◽  
Vol 6 (4) ◽  
pp. 249
Author(s):  
N.J. Bundred ◽  
J. Reynolds ◽  
D. Allen ◽  
J. Rees ◽  
J. Grimshaw ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025742 ◽  
Author(s):  
An De Groef ◽  
Nele Devoogdt ◽  
Elien Van der Gucht ◽  
Lore Dams ◽  
Koen Bernar ◽  
...  

IntroductionOver the past decades, awareness on the importance of educational interventions in cancer pain management has increased. However, education is often restricted to biomedical pain management instructions. A more modern educational approach, also known as pain neuroscience education (PNE), explains pain from a biopsychosocial perspective. We hypothesise that this more comprehensive educational approach in the early treatment phase of breast cancer will lead to more beneficial effects for cancer pain management. Therefore, the aim of the present study is to investigate the effectiveness of this PNE intervention, in addition to best evidence physical therapy modalities for treatment and prevention of pain, physical, emotional and work-related functioning after breast cancer surgery, compared with a traditional biomedical educational intervention.MethodsA double-blinded randomised controlled trial has been started in November 2017 at the University Hospitals of Leuven. Immediately after breast cancer surgery, all participants (n=184) receive a 12-week intensive standard physical therapy programme. They receive three additional refresher sessions at 6, 8 and 12 months postsurgery. In addition, participants receive three educational sessions during the first-month postsurgery and three ‘booster sessions’ at 6, 8 and 12 months postsurgery. In the intervention group, the content of the education sessions is based on the modern PNE approach. Whereas in the control group, the education is based on the traditional biomedical approach. The primary outcome parameter is pain-related disability 1 year after surgery. Secondary outcomes related to other dimensions of pain, physical, emotional and work-related functioning at 1-week, 4, 6, 8, 12 and 18 months postsurgery.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals of Leuven. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses.Trial registration numberNCT03351075.


BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019078 ◽  
Author(s):  
Julie Bruce ◽  
Esther Williamson ◽  
Clare Lait ◽  
Helen Richmond ◽  
Lauren Betteley ◽  
...  

Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery.MethodsThis pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions.DiscussionThe PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation.Protocol versionVersion 2.1; dated 11 January 2017Trial registration numberISRCTN35358984; Pre-results.


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