scholarly journals Ultrasound-guided erector spinae plane catheter versus video-assisted paravertebral catheter placement in minimally invasive thoracic surgery: comparing continuous infusion analgesic techniques on early quality of recovery, respiratory function and chronic persistent surgical pain: study protocol for a double-blinded randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aneurin Moorthy ◽  
Aisling Ni Eochagain ◽  
Eamon Dempsey ◽  
Donal Buggy
Keyword(s):  
Postoperative Pain ◽  
Thoracic Surgery ◽  
Short Form ◽  
Controlled Trial ◽  
Erector Spinae ◽  
Ultrasound Guided ◽  
Quality Of Recovery ◽  
Video Assisted ◽  
Randomised Controlled

Abstract Background Compared to conventional thoracotomy, minimally invasive thoracic surgery (MITS) can reduce postoperative pain, reduce tissue trauma and contribute to better recovery. However, it still causes significant acute postoperative pain. Truncal regional anaesthesia techniques such as paravertebral and erector spinae blocks have shown to contribute to postoperative analgesia after MITS. Satisfactory placement of an ultrasound-guided thoracic paravertebral catheter can be technically challenging compared to an ultrasound-guided erector spinae catheter. However, in MITS, an opportunity arises for directly visualised placement of a paravertebral catheter by the surgeon under thoracoscopic guidance. Alongside with thoracic epidural, a paravertebral block is considered the “gold standard” of thoracic regional analgesic techniques. To the best of our knowledge, there are no randomised controlled trials comparing surgeon-administered paravertebral catheter and anaesthesiologist-assisted erector spinae catheter for MITS in terms of patient-centred outcomes such as quality of recovery. Methods This trial will be a prospective, double-blinded randomised controlled trial. A total of 80 eligible patients will be randomly assigned to receive either an anaesthesiologist-assisted ultrasound-guided erector spinae catheter or a surgeon-assisted video-assisted paravertebral catheter, in a 1:1 ratio following induction of general anaesthesia for minimally assisted thoracic surgery. Both groups will receive the same standardised analgesia protocol for both intra- and postoperative periods. The primary outcome is defined as Quality of Recovery (QoR-15) score between the two groups at 24 h postoperative. Secondary outcomes include assessment of chronic persistent surgical pain (CPSP) at 3 months postoperative using the Brief Pain Inventory (BPI) Short Form and Short Form McGill (SF-15) questionnaires, assessment of postoperative pulmonary function, area under the curve for Verbal Rating Score for pain at rest and on deep inspiration versus time over 48 h, total opioid consumption over 48 h, QoR-15 at 48 h, and postoperative complications and morbidity as measured by the Comprehensive Complication Index. Discussion Despite surgical advancements in thoracic surgery, severe acute postoperative pain following MITS is still prevailing. This study will provide recommendations about the efficacy of an anaesthesia-administered ultrasound-guided erector spinae catheter or surgeon-administered, video-assisted paravertebral catheter techniques for early quality of recovery following MITS. Trial registration ClinicalTrials.govNCT04729712. Registered on 28 January 2021. All items from the World Health Organization Trial Registration Data Set have been included.

scholarly journals Ultrasound Guided Erector Spinae Plane Catheter Versus Video-Assisted Paravertebral Catheter Placement in Minimally Invasive Thoracic Surgery: Comparing Continuous Infusion Analgesic Techniques on Early Quality of Recovery, Respiratory Function and Chronic Persistent Surgical Pain: Study Protocol for A Double-Blinded Randomised Controlled Trial.

2021 ◽  
Author(s):  
Aneurin Moorthy ◽  
Aisling Ni Eochagain ◽  
Eamon Dempsey ◽  
Donal Buggy
Keyword(s):  
Thoracic Surgery ◽  
Short Form ◽  
Controlled Trial ◽  
Erector Spinae ◽  
Ultrasound Guided ◽  
Quality Of Recovery ◽  
Video Assisted ◽  
Randomised Controlled ◽  
Double Blinded

Abstract Background: Compared to conventional thoracotomy, minimally invasive thoracic surgery (MITS) can reduce postoperative pain, reduce tissue trauma and contribute to better recovery. However, it still causes significant acute post-operative pain. Truncal regional anaesthesia techniques such as paravertebral and Erector Spinae blocks have shown to contribute to post-operative analgesia after MITS. Satisfactory placement of an ultrasound guided thoracic paravertebral catheter can be technically challenging compared to ultrasound guided Erector Spinae catheter. However, in MITS an opportunity arises for directly visualised placement of a paravertebral catheter by the surgeon under thoracoscopic guidance. Alongside with thoracic epidural, paravertebral block is considered the “gold standard” of thoracic regional analgesic techniques. To best of our knowledge, there are no randomised controlled trials comparing Surgeon-administered Paravertebral catheter and Anaesthesiologist-assisted Erector Spinae catheter for MITS in terms of patient centred outcomes such as quality of recovery.Methods: This trial will be a prospective, double-blinded randomised controlled trial. A total of 80 eligible patients will be randomly assigned to receive either an Anaesthesiologist-assisted ultrasound guided Erector Spinae catheter or Surgeon-assisted video-assisted Paravertebral catheter, in a 1:1 ratio following induction of general anaesthesia for minimally assisted thoracic surgery. Both groups will receive the same standardized analgesia protocol for both intra and postoperative periods. The primary outcome is defined as Quality of Recovery (QoR-15) score between the two groups at 24 & 48 hours postoperative. Secondary outcomes include assessment of chronic persistent surgical pain (CPSP) at 3 months post-operative using Brief Pain Inventory (BPI) Short Form and Short Form McGill (SF-15) questionnaires, assessment of post-operative pulmonary function, area Under the Curve for Verbal Rating Score for pain at rest and on deep inspiration versus time over 48 hours, total opioid consumption over 48 hours and post-operative complications and morbidity as measured by the Comprehensive Complication Index. Discussion: Despite surgical advancements in thoracic surgery, severe acute post-operative pain following MITS is still prevailing. This study will provide recommendations about the efficacy of anaesthesia-administered ultrasound guided Erector Spinae catheter or surgeon-administered, video assisted paravertebral catheter techniques for early quality of recovery following MITS. Trial registration: This trial was pre-registered on ClinicalTrials.gov Identifier: NCT04729712. Registered on 28 January 2021. All item from the World Health Organisation Trial Regsitration Data set have been included. https://clinicaltrials.gov/ct2/show/NCT04729712

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

Epipleural surgical block and ultrasound-guided erector spinae plane block for analgesia in VATS

2021 ◽  
Keyword(s):  
Postoperative Pain ◽  
Thoracic Surgery ◽  
Postoperative Analgesia ◽  
Local Anesthetic ◽  
Erector Spinae ◽  
Ultrasound Guided ◽  
Additional Method ◽  
Video Tutorial ◽  
Erector Spinae Plane Block ◽  
Severe Postoperative Pain

Thoracic surgery is still associated with severe postoperative pain. In this video tutorial, we present 2 techniques that could be used as an additional method in a multimodal postoperative analgesia strategy for video-assisted thoracic surgery. We present the combination of an epipleural surgical infiltration of a local anesthetic with an ultrasound-guided erector spinae plane block.

scholarly journals Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e023162
Author(s):  
Jilin Chen ◽  
Ying Liu ◽  
Xiangmei Chen ◽  
Xuefeng Sun ◽  
Wei Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Medical Costs ◽  
Dialysis Initiation ◽  
Fuzzy Mathematics ◽  
Late Start ◽  
Randomised Controlled

IntroductionStarting dialysis early or late both result in a low quality of life and a poor prognosis in patients undergoing haemodialysis. However, there remains no consensus on the optimal timing of dialysis initiation, mainly because of a lack of suitable methods to assess variations in dialysis initiation time. We have established a novel equation named DIFE (Dialysis Initiation based on Fuzzy-mathematics Equation) through a retrospective, multicentre clinical cohort study in China to determine the most suitable timing of dialysis initiation. The predictors of the DIFE include nine biochemical markers and clinical variables that together influence dialysis initiation. To externally validate the clinical accuracy of DIFE, we designed the assessment of DIFE (ADIFE) study as a prospective, open-label, multicentre, randomised controlled trial to assess the clinical outcomes among patients who initiate dialysis in an optimal start dialysis group and a late-start dialysis group, based on DIFE.Methods and analysisA total of 388 enrolled patients with end-stage renal disease will be randomised 1:1 to the optimal start dialysis group, with a DIFE value between 30 and 35, or the late-start dialysis group, with a DIFE value less than 30, using the Randomization and Trial Supply Management system. Participants will be assessed for changes in signs and symptoms, dialysis mode and parameters, biochemical and inflammatory markers, Subjective Global Assessment, Kidney Disease Quality of Life Short Form, Cognitive Assessment, medical costs, adverse events and concomitant medication at baseline, predialysis visiting stage and postdialysis visiting stage, every 12–24 weeks. The following data will be recorded on standardised online electronic case report forms. The primary endpoint is 3-year all-cause mortality. The secondary endpoints include non-fatal cerebrocardiovascular events, annual hospitalisation rate, quality of life, medical costs and haemodialysis related complications.Ethics and disseminationEthical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Dalian Medical University China (registration no: YJ-KY-2017–119) and the ethics committees of all participating centres. The final results of the ADIFE trial will be presented to the study sponsor, clinical researchers and the patient and public involvement reference group. Findings will be disseminated through peer-reviewed journals, Clinical Practice Guidelines and at scientific meetings.Trial registration numberClinicalTrial.gov. Registry (NCT03385902); pre-results.

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Electroacupuncture Treatment

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This trial protocol provides an example of clinical application for the management of postoperative pain using electroacupuncture treatment. If the electroacupuncture treatment protocol confirms that this treatment method is effective and safe, it can be implemented as a standard of care for relieving postoperative pain in Chinese and Western medicine.

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