A randomised controlled trial evaluating the effect of Pre-operative oral gabapentin on postoperative pain relief and opioid consumption in patients undergoing modified radical mastectomy

2020 ◽  
Vol 16 (2) ◽  
pp. 28-32
Author(s):  
Shankar Anand R ◽  
Keyword(s):  
Postoperative Pain ◽  
Randomised Controlled Trial ◽  
Pain Relief ◽  
Controlled Trial ◽  
Radical Mastectomy ◽  
Opioid Consumption ◽  
Postoperative Pain Relief ◽  
Modified Radical Mastectomy ◽  
Randomised Controlled

scholarly journals Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e048270
Author(s):  
Pablo Kappen ◽  
Johannes Jeekel ◽  
Clemens M F Dirven ◽  
M Klimek ◽  
Steven Kushner ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomised Controlled Trial ◽  
Medical Center ◽  
Controlled Trial ◽  
Clinical Care ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Depth Of Anaesthesia ◽  
Randomised Controlled

IntroductionDelirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress.Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality.Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes.MethodsThis protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical careDelirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected.Ethics and disseminationThis study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numbersNL8503 and NCT04649450.

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