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 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.

Ultrasound-guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Block on Alleviating the Acute and Chronic Pain Following the Video-assisted Thoracic Surgery: a Prospective, Randomized, Double-blinded Non-inferiority Clinical Trial

2021 ◽  
Author(s):  
Yan Wang ◽  
Jing Hao ◽  
Simin Huang ◽  
Xiaoping Gu ◽  
Zhengliang Ma
Keyword(s):  
Clinical Trial ◽  
Chronic Pain ◽  
Thoracic Surgery ◽  
Ultrasound Guided ◽  
Video Assisted Thoracic Surgery ◽  
Video Assisted ◽  
Vas Scores ◽  
Secondary Outcomes ◽  
Double Blinded ◽  
Anterior Plane

Abstract Background: The anesthetic efficacy of ultrasound-guided serrate anterior plane block (SAPB) on alleviating postoperative acute and chronic pain has been well concerned. The present study aims to compare the efficacy between ultrasound-guided SAPB and thoracic paravertebral block (PVB) on alleviating both acute pain and chronic pain following the video-assisted thoracic surgery. Methods: It was a prospective, randomized, double-blinded non-inferiority clinical trial involving 99 patients with lung nodules receiving video-assisted thoracic surgery with ultrasound-guided SAPB (SAPB group) or PVB (PVB group) on T4 and T7 vertebra using 0.375% ropivacaine at 2 mg/kg. The Visual Analogue Scale (VAS) scores at both rest and cough at 24 h postoperatively were graded as the primary outcome. Besides, secondary outcomes included the incidence of chronic pain at 3 and 6 months postoperatively, VAS scores at rest and cough at 1, 6, 12 and 48 h postoperatively, consumptions of fentanyl and remifentanyl, and the pressing times of the patient-controlled analgesia (PCA) pump. Baseline characteristics, surgery characteristics and primary and secondary outcomes between groups were compared. Results: A total of 92 eligible patients were recruited, including 46 in SAPB group and 46 in PVB group. Baseline and surgery characteristics between groups were comparable (all P>0.05). No significant differences in VAS scores at rest and cough at 1 h, 6 h, 12 h, 24 h, 48 h, 3 months and 6 months postoperatively between SAPB group and PVB group were detected (all P>0.05). Conclusion: The anesthetic efficacy of ultrasound-guided SAPB was not inferior to PVB on alleviating postoperative acute and chronic pain following the video-assisted thoracic surgery.Trial registration number: retrospective registered in the Chinese Clinical Trial Registry (ChiCTR2100050991, http://www.chictr.org.cn, 09/09/2021, Yan Wang, MD).

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 Improved Analgesic Effect of Paravertebral Blocks before and after Video-Assisted Thoracic Surgery: A Prospective, Double-Blinded, Randomized Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Lihua Chu ◽  
Xiaolin Zhang ◽  
Yaping Lu ◽  
Guohao Xie ◽  
Shengwen Song ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Thoracic Surgery ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Video Assisted Thoracic Surgery ◽  
Randomized Controlled ◽  
Video Assisted ◽  
Group A ◽  
Group B ◽  
Double Blinded

Despite being less invasive, patients who underwent video-assisted thoracic surgery (VATS) suffered considerable postoperative pain. Paravertebral block (PVB) was proven to provide effective analgesia in patients with VATS; however, there is no difference in pain relief between preoperative PVB and postoperative PVB. This study was aimed to investigate the analgesic efficacy of combination of preoperative and postoperative PVB on the same patient undergoing VATS. In this prospective, double-blinded, randomized controlled trial, 44 patients undergoing VATS were enrolled, and they received patient-controlled intravenous analgesia (PCIA) with sufentanil plus preoperative PVB (Group A, n = 15) or postoperative PVB (Group B, n = 15), or combination of preoperative and postoperative PVB (Group C, n = 14). The primary outcome was sufentanil consumption and PCIA press times in the first 24 hours postoperatively. Also, data of postoperative use of PCIA and visual analogue scale (VAS) were collected. In the first 24 hours postoperatively, median sufentanil consumption in Group C was 0 (0–34.75) μg, which was much less than that in Group A (45.00 (33.00–47.00) μg, p=0.005) and Group B (36 (20.00–50.00) μg, p=0.023). Patients in Group C pressed less times of PCIA (0 (0–0) times) than patients in Group A (2 (1–6) times, p<0.001) and Group B (2 (1–3) times, p=0.009). Kaplan–Meier analysis showed patients with combination of preoperative and postoperative PVB had a higher PCIA-free rate than patients with either technique alone (p=0.003). The VAS among the three groups was comparable postoperatively. The combination of both preoperative and postoperative PVB provides better analgesic efficacy during the early postoperative period and may be an alternative option for pain control after VATS. This trial is registered with ChiCTR1800017102.

Systemic Lidocaine to Improve Quality of Recovery after Laparoscopic Bariatric Surgery: A Randomized Double-Blinded Placebo-Controlled Trial

2013 ◽  
Vol 24 (2) ◽  
pp. 212-218 ◽  
Author(s):  
Gildasio S. De Oliveira ◽  
Kenyon Duncan ◽  
Paul Fitzgerald ◽  
Antoun Nader ◽  
Robert W. Gould ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Controlled Trial ◽  
Laparoscopic Bariatric Surgery ◽  
Improve Quality ◽  
Quality Of Recovery ◽  
Double Blinded
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