Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial

Publication Date:
2018-01-28
Publisher:
BMJ Publishing
Electronic ISSN:
2044-6055
Topics:
Medicine
Keywords:
Open access, Anaesthesia
Published by:
http://group.bmj.com/
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autor Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
beschreibung Introduction Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial. Methods The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival. Ethics and dissemination The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration number NCT02681796.
citation_standardnr 6148034
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insertion_date 2018-01-28
journaleissn 2044-6055
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
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relation http://bmjopen.bmj.com/cgi/content/short/8/1/e018787?rss=1
schlagwort Open access, Anaesthesia
search_space articles
shingle_author_1 Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
shingle_author_2 Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
shingle_author_3 Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
shingle_author_4 Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
shingle_catch_all_1 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
Open access, Anaesthesia
Introduction Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial. Methods The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival. Ethics and dissemination The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration number NCT02681796.
Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_2 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
Open access, Anaesthesia
Introduction Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial. Methods The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival. Ethics and dissemination The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration number NCT02681796.
Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_3 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
Open access, Anaesthesia
Introduction Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial. Methods The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival. Ethics and dissemination The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration number NCT02681796.
Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_4 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
Open access, Anaesthesia
Introduction Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial. Methods The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival. Ethics and dissemination The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration number NCT02681796.
Pak, L. M., Haroutounian, S., Hawkins, W. G., Worley, L., Kurtz, M., Frey, K., Karanikolas, M., Swarm, R. A., Bottros, M. M.
BMJ Publishing
2044-6055
20446055
shingle_title_1 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
shingle_title_2 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
shingle_title_3 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
shingle_title_4 Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
timestamp 2025-06-30T23:32:17.762Z
titel Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
titel_suche Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial
topic WW-YZ
uid ipn_articles_6148034