Clinical trial NCT06563557: Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy
Official title: ERASME ULB: Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy - a Double Blind Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esophagectomy
Epidural; Anesthesia
Paravertebral Anesthesia
Hemodynamic Instability
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.


Eligibility criteria: Inclusion Criteria:

* Adult, Capable of giving consent, two or three incisions esophagectomy (thoracoscopic/ thoracotomy) no laparotomy

Exclusion Criteria:

* patient refusal, total language barrier, coagulation disorders, thrombocytopenia \<75 000, contraindications to locoregional anesthesia (infection local site, allergy to local anesthesic), scoliosis Cobb \> 45%, atrial fibrillation, end stage renal disease),

Primary outcomes:
measure: Consumption of norepinephrine and fluids during procedure
timeFrame: 6 hours
Secondary outcomes:
measure: Postoperative complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Laszlo.szegedi@hubruxelles.be
name: Laszlo SZEGEDI, PHD
role: STUDY_CHAIR
References:
citation: Low DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4.
citation: Deana C, Vetrugno L, Bignami E, Bassi F. Peri-operative approach to esophagectomy: a narrative review from the anesthesiological standpoint. J Thorac Dis. 2021 Oct;13(10):6037-6051. doi: 10.21037/jtd-21-940.
citation: Kingma BF, Eshuis WJ, de Groot EM, Feenstra ML, Ruurda JP, Gisbertz SS, Ten Hoope W, Marsman M, Hermanides J, Hollmann MW, Kalkman CJ, Luyer MDP, Nieuwenhuijzen GAP, Scholten HJ, Buise M, van Det MJ, Kouwenhoven EA, van der Meer F, Frederix GWJ, Cheong E, Al Naimi K, van Berge Henegouwen MI, van Hillegersberg R. Paravertebral catheter versus EPidural analgesia in Minimally invasive Esophageal resectioN: a randomized controlled multicenter trial (PEPMEN trial). BMC Cancer. 2020 Feb 22;20(1):142. doi: 10.1186/s12885-020-6585-1.
citation: van den Berg JW, Tabrett K, Cheong E. Paravertebral catheter analgesia for minimally invasive Ivor Lewis oesophagectomy. J Thorac Dis. 2019 Apr;11(Suppl 5):S786-S793. doi: 10.21037/jtd.2019.03.47.
citation: Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.