Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial

Rosa Klotz; Azaz Ahmed; Anja Tremmel; Christopher Büsch; Solveig Tenckhoff; Colette Doerr-Harim; Johan F. Lock; Elmar Marc Brede; Jörg Köninger; Jan Henrik Schiff; Uwe A. Wittel; Alexander Hötzel; Tobias Keck; Carla Nau; Anca Laura Amati; Christian Koch; Markus K. Diener; Markus A. Weigand; Markus W. Büchler; Phillip Knebel; Jan Larmann

doi:10.1213/ANE.0000000000006812

Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial

Rosa Klotz^*, Azaz Ahmed, Anja Tremmel, Christopher Büsch, Solveig Tenckhoff, Colette Doerr-Harim, Johan F. Lock, Elmar Marc Brede, Jörg Köninger, Jan Henrik Schiff, Uwe A. Wittel, Alexander Hötzel, Tobias Keck, Carla Nau, Anca Laura Amati, Christian Koch, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Phillip KnebelJan Larmann

^*Korrespondierende/r Autor/-in für diese Arbeit

5 Zitate (Scopus)

Abstract

BACKGROUND: Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery. METHODS: The PAKMAN trial was an adaptive, pragmatic, international, multicenter, randomized controlled superiority trial conducted from June 2015 to October 2017. Three to five years after index surgery a long-term follow-up was performed from October 2020 to April 2021. RESULTS: For long-term follow-up of survival, 109 patients with EDA were compared to 111 patients with PCIA after partial pancreatoduodenectomy (PD). Long-term follow-up of quality of life (QoL) and pain assessment was available for 40 patients with EDA and 45 patients with PCIA (questionnaire response rate: 94%). Survival analysis revealed that EDA, when compared to PCIA, was not associated with improved overall survival (OS, HR, 1.176, 95% HR-CI, 0.809–1.710, P = .397, n = 220). Likewise, recurrence-free survival did not differ between groups (HR, 1.116, 95% HR-CI, 0.817–1.664, P = .397, n = 220). OS subgroup analysis including only patients with malignancies showed no significant difference between EDA and PCIA (HR, 1.369, 95% HR-CI, 0.932–2.011, P = .109, n = 179). Similar long-term effects on QoL and pain severity were observed in both groups (EDA: n = 40, PCIA: n = 45). CONCLUSIONS: Results from this long-term follow-up of the PAKMAN randomized controlled trial do not support favoring EDA over PCIA in pancreatic surgery. Until further evidence is available, EDA and PCIA should be considered similar regarding long-term survival.

Originalsprache	Englisch
Zeitschrift	Anesthesia and Analgesia
Jahrgang	140
Ausgabenummer	4
Seiten (von - bis)	798-810
Seitenumfang	13
ISSN	0003-2999
DOIs	https://doi.org/10.1213/ANE.0000000000006812
Publikationsstatus	Veröffentlicht - 01.04.2025

Fördermittel

The initial PAKMAN trial was an investigator-initiated trial financed by the Dietmar Hopp Foundation. This long-term follow-up was an investigator-initiated trial and was supported by the University Hospital Heidelberg. No additional funding was obtained. We thank the staff of all participating centers of the PAKMAN trial group for their outstanding commitment and support of the trial. Furthermore, we would like to thank the nursing staff and the clinical partners who were not directly involved in conducting this trial but without whom its successful completion would not have been possible.

Träger	Trägernummer
Dietmar Hopp Foundation
Ruprecht-Karls-Universität Heidelberg

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10.1213/ANE.0000000000006812

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Klotz, R., Ahmed, A., Tremmel, A., Büsch, C., Tenckhoff, S., Doerr-Harim, C., Lock, J. F., Brede, E. M., Köninger, J., Schiff, J. H., Wittel, U. A., Hötzel, A., Keck, T., Nau, C., Amati, A. L., Koch, C., Diener, M. K., Weigand, M. A., Büchler, M. W., ... Larmann, J. (2025). Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial. Anesthesia and Analgesia, 140(4), 798-810. https://doi.org/10.1213/ANE.0000000000006812

@article{a71025f4f4ed42908ea76548c42ebba9,

title = "Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial",

abstract = "BACKGROUND: Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery. METHODS: The PAKMAN trial was an adaptive, pragmatic, international, multicenter, randomized controlled superiority trial conducted from June 2015 to October 2017. Three to five years after index surgery a long-term follow-up was performed from October 2020 to April 2021. RESULTS: For long-term follow-up of survival, 109 patients with EDA were compared to 111 patients with PCIA after partial pancreatoduodenectomy (PD). Long-term follow-up of quality of life (QoL) and pain assessment was available for 40 patients with EDA and 45 patients with PCIA (questionnaire response rate: 94\%). Survival analysis revealed that EDA, when compared to PCIA, was not associated with improved overall survival (OS, HR, 1.176, 95\% HR-CI, 0.809–1.710, P = .397, n = 220). Likewise, recurrence-free survival did not differ between groups (HR, 1.116, 95\% HR-CI, 0.817–1.664, P = .397, n = 220). OS subgroup analysis including only patients with malignancies showed no significant difference between EDA and PCIA (HR, 1.369, 95\% HR-CI, 0.932–2.011, P = .109, n = 179). Similar long-term effects on QoL and pain severity were observed in both groups (EDA: n = 40, PCIA: n = 45). CONCLUSIONS: Results from this long-term follow-up of the PAKMAN randomized controlled trial do not support favoring EDA over PCIA in pancreatic surgery. Until further evidence is available, EDA and PCIA should be considered similar regarding long-term survival.",

author = "Rosa Klotz and Azaz Ahmed and Anja Tremmel and Christopher B{\"u}sch and Solveig Tenckhoff and Colette Doerr-Harim and Lock, \{Johan F.\} and Brede, \{Elmar Marc\} and J{\"o}rg K{\"o}ninger and Schiff, \{Jan Henrik\} and Wittel, \{Uwe A.\} and Alexander H{\"o}tzel and Tobias Keck and Carla Nau and Amati, \{Anca Laura\} and Christian Koch and Diener, \{Markus K.\} and Weigand, \{Markus A.\} and B{\"u}chler, \{Markus W.\} and Phillip Knebel and Jan Larmann",

note = "Publisher Copyright: Copyright {\textcopyright} 2025 International Anesthesia Research Society.",

year = "2025",

month = apr,

day = "1",

doi = "10.1213/ANE.0000000000006812",

language = "English",

volume = "140",

pages = "798--810",

journal = "Anesthesia and Analgesia",

issn = "0003-2999",

publisher = "Lippincott Williams and Wilkins",

number = "4",

}

Klotz, R, Ahmed, A, Tremmel, A, Büsch, C, Tenckhoff, S, Doerr-Harim, C, Lock, JF, Brede, EM, Köninger, J, Schiff, JH, Wittel, UA, Hötzel, A, Keck, T , Nau, C, Amati, AL, Koch, C, Diener, MK, Weigand, MA, Büchler, MW, Knebel, P & Larmann, J 2025, 'Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial', Anesthesia and Analgesia, Jg. 140, Nr. 4, S. 798-810. https://doi.org/10.1213/ANE.0000000000006812

Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial. / Klotz, Rosa; Ahmed, Azaz; Tremmel, Anja et al.
in: Anesthesia and Analgesia, Jahrgang 140, Nr. 4, 01.04.2025, S. 798-810.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery

T2 - Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial

AU - Klotz, Rosa

AU - Ahmed, Azaz

AU - Tremmel, Anja

AU - Büsch, Christopher

AU - Tenckhoff, Solveig

AU - Doerr-Harim, Colette

AU - Lock, Johan F.

AU - Brede, Elmar Marc

AU - Köninger, Jörg

AU - Schiff, Jan Henrik

AU - Wittel, Uwe A.

AU - Hötzel, Alexander

AU - Keck, Tobias

AU - Nau, Carla

AU - Amati, Anca Laura

AU - Koch, Christian

AU - Diener, Markus K.

AU - Weigand, Markus A.

AU - Büchler, Markus W.

AU - Knebel, Phillip

AU - Larmann, Jan

PY - 2025/4/1

Y1 - 2025/4/1

N2 - BACKGROUND: Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery. METHODS: The PAKMAN trial was an adaptive, pragmatic, international, multicenter, randomized controlled superiority trial conducted from June 2015 to October 2017. Three to five years after index surgery a long-term follow-up was performed from October 2020 to April 2021. RESULTS: For long-term follow-up of survival, 109 patients with EDA were compared to 111 patients with PCIA after partial pancreatoduodenectomy (PD). Long-term follow-up of quality of life (QoL) and pain assessment was available for 40 patients with EDA and 45 patients with PCIA (questionnaire response rate: 94%). Survival analysis revealed that EDA, when compared to PCIA, was not associated with improved overall survival (OS, HR, 1.176, 95% HR-CI, 0.809–1.710, P = .397, n = 220). Likewise, recurrence-free survival did not differ between groups (HR, 1.116, 95% HR-CI, 0.817–1.664, P = .397, n = 220). OS subgroup analysis including only patients with malignancies showed no significant difference between EDA and PCIA (HR, 1.369, 95% HR-CI, 0.932–2.011, P = .109, n = 179). Similar long-term effects on QoL and pain severity were observed in both groups (EDA: n = 40, PCIA: n = 45). CONCLUSIONS: Results from this long-term follow-up of the PAKMAN randomized controlled trial do not support favoring EDA over PCIA in pancreatic surgery. Until further evidence is available, EDA and PCIA should be considered similar regarding long-term survival.

AB - BACKGROUND: Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery. METHODS: The PAKMAN trial was an adaptive, pragmatic, international, multicenter, randomized controlled superiority trial conducted from June 2015 to October 2017. Three to five years after index surgery a long-term follow-up was performed from October 2020 to April 2021. RESULTS: For long-term follow-up of survival, 109 patients with EDA were compared to 111 patients with PCIA after partial pancreatoduodenectomy (PD). Long-term follow-up of quality of life (QoL) and pain assessment was available for 40 patients with EDA and 45 patients with PCIA (questionnaire response rate: 94%). Survival analysis revealed that EDA, when compared to PCIA, was not associated with improved overall survival (OS, HR, 1.176, 95% HR-CI, 0.809–1.710, P = .397, n = 220). Likewise, recurrence-free survival did not differ between groups (HR, 1.116, 95% HR-CI, 0.817–1.664, P = .397, n = 220). OS subgroup analysis including only patients with malignancies showed no significant difference between EDA and PCIA (HR, 1.369, 95% HR-CI, 0.932–2.011, P = .109, n = 179). Similar long-term effects on QoL and pain severity were observed in both groups (EDA: n = 40, PCIA: n = 45). CONCLUSIONS: Results from this long-term follow-up of the PAKMAN randomized controlled trial do not support favoring EDA over PCIA in pancreatic surgery. Until further evidence is available, EDA and PCIA should be considered similar regarding long-term survival.

UR - https://www.scopus.com/pages/publications/105000329681

U2 - 10.1213/ANE.0000000000006812

DO - 10.1213/ANE.0000000000006812

M3 - Journal articles

C2 - 38335141

AN - SCOPUS:105000329681

SN - 0003-2999

VL - 140

SP - 798

EP - 810

JO - Anesthesia and Analgesia

JF - Anesthesia and Analgesia

IS - 4

ER -

Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial

Abstract

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