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Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial

BACKGROUND: Postoperative pain prevention is essential for the recovery of surgical patients. Continuous (thoracic) epidural analgesia (CEA) is routinely practiced for major abdominal surgery, but evidence is conflicting on its benefits in this setting. Potential disadvantages of epidural analgesia...

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Autores principales: Mungroop, Timothy H., Veelo, Denise P., Busch, Olivier R., van Dieren, Susan, van Gulik, Thomas M., Karsten, Tom M., de Castro, Steve M., Godfried, Marc B., Thiel, Bram, Hollmann, Markus W., Lirk, Philipp, Besselink, Marc G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674956/
https://www.ncbi.nlm.nih.gov/pubmed/26654448
http://dx.doi.org/10.1186/s13063-015-1075-5
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author Mungroop, Timothy H.
Veelo, Denise P.
Busch, Olivier R.
van Dieren, Susan
van Gulik, Thomas M.
Karsten, Tom M.
de Castro, Steve M.
Godfried, Marc B.
Thiel, Bram
Hollmann, Markus W.
Lirk, Philipp
Besselink, Marc G.
author_facet Mungroop, Timothy H.
Veelo, Denise P.
Busch, Olivier R.
van Dieren, Susan
van Gulik, Thomas M.
Karsten, Tom M.
de Castro, Steve M.
Godfried, Marc B.
Thiel, Bram
Hollmann, Markus W.
Lirk, Philipp
Besselink, Marc G.
author_sort Mungroop, Timothy H.
collection PubMed
description BACKGROUND: Postoperative pain prevention is essential for the recovery of surgical patients. Continuous (thoracic) epidural analgesia (CEA) is routinely practiced for major abdominal surgery, but evidence is conflicting on its benefits in this setting. Potential disadvantages of epidural analgesia are a) perioperative hypotension, frequently requiring additional intravenous fluid boluses or prolonged use of vasopressors; b) relatively high failure rates, with periods of inadequate analgesia; and c) the risk of rare but serious, at times persistent, neurologic complications (hematoma and abscess). In recent years, continuous (subfascial) wound infiltration (CWI) plus patient-controlled analgesia (PCA) has been suggested as a safe and reliable alternative, which does not have the previously mentioned disadvantages, but evidence from multicenter trials targeting a specific surgical population is lacking. We hypothesize that CWI+PCA is equally as effective as CEA, without the mentioned disadvantages. METHODS/DESIGN: POP-UP is a randomized controlled noninferiority multicenter trial, recruiting adult patients scheduled for elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. A total of 102 patients are being randomly allocated to CWI+PCA or (P)CEA. Our primary endpoint is the Overall Benefit of Analgesic Score (OBAS), a composite endpoint of pain intensity, opioid-related adverse effects and patient satisfaction, during postoperative days 1 to 5. Secondary endpoints include length of the hospital stay, number of patients with severe pain, and the use of rescue medication. DISCUSSION: POP-UP is a pragmatic trial that will provide evidence of whether CWI+PCA is noninferior as compared to (P)CEA after elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique, especially when the described disadvantages of epidural analgesia are less often observed with CWI+PCA. TRIAL REGISTRATION: Netherlands Trial Register NTR4948 (registry date 2 January 2015).
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spelling pubmed-46749562015-12-11 Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial Mungroop, Timothy H. Veelo, Denise P. Busch, Olivier R. van Dieren, Susan van Gulik, Thomas M. Karsten, Tom M. de Castro, Steve M. Godfried, Marc B. Thiel, Bram Hollmann, Markus W. Lirk, Philipp Besselink, Marc G. Trials Study Protocol BACKGROUND: Postoperative pain prevention is essential for the recovery of surgical patients. Continuous (thoracic) epidural analgesia (CEA) is routinely practiced for major abdominal surgery, but evidence is conflicting on its benefits in this setting. Potential disadvantages of epidural analgesia are a) perioperative hypotension, frequently requiring additional intravenous fluid boluses or prolonged use of vasopressors; b) relatively high failure rates, with periods of inadequate analgesia; and c) the risk of rare but serious, at times persistent, neurologic complications (hematoma and abscess). In recent years, continuous (subfascial) wound infiltration (CWI) plus patient-controlled analgesia (PCA) has been suggested as a safe and reliable alternative, which does not have the previously mentioned disadvantages, but evidence from multicenter trials targeting a specific surgical population is lacking. We hypothesize that CWI+PCA is equally as effective as CEA, without the mentioned disadvantages. METHODS/DESIGN: POP-UP is a randomized controlled noninferiority multicenter trial, recruiting adult patients scheduled for elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. A total of 102 patients are being randomly allocated to CWI+PCA or (P)CEA. Our primary endpoint is the Overall Benefit of Analgesic Score (OBAS), a composite endpoint of pain intensity, opioid-related adverse effects and patient satisfaction, during postoperative days 1 to 5. Secondary endpoints include length of the hospital stay, number of patients with severe pain, and the use of rescue medication. DISCUSSION: POP-UP is a pragmatic trial that will provide evidence of whether CWI+PCA is noninferior as compared to (P)CEA after elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique, especially when the described disadvantages of epidural analgesia are less often observed with CWI+PCA. TRIAL REGISTRATION: Netherlands Trial Register NTR4948 (registry date 2 January 2015). BioMed Central 2015-12-09 /pmc/articles/PMC4674956/ /pubmed/26654448 http://dx.doi.org/10.1186/s13063-015-1075-5 Text en © Mungroop et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Mungroop, Timothy H.
Veelo, Denise P.
Busch, Olivier R.
van Dieren, Susan
van Gulik, Thomas M.
Karsten, Tom M.
de Castro, Steve M.
Godfried, Marc B.
Thiel, Bram
Hollmann, Markus W.
Lirk, Philipp
Besselink, Marc G.
Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial
title Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial
title_full Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial
title_fullStr Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial
title_full_unstemmed Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial
title_short Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial
title_sort continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (pop-up trial): study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674956/
https://www.ncbi.nlm.nih.gov/pubmed/26654448
http://dx.doi.org/10.1186/s13063-015-1075-5
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