Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy

NCT06563557 | Not Yet Recruiting

• 1 other identifier: P2023/514 /B4062024000032
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophagectomy; Epidural; Anesthesia; Paravertebral Anesthesia; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Consumption of norepinephrine and fluids during procedure

  norepinephrine mcg/kg/hr

  6 hours

Secondary Outcomes (1)

• Postoperative complications

  6 months

Study Arms (2)

Epidural group

ACTIVE COMPARATOR

Other: Hemodynamic changes between epidural and paravertebral during esophagectomy

Paravertebral group

EXPERIMENTAL

Other: Hemodynamic changes between epidural and paravertebral during esophagectomy

Interventions

Hemodynamic changes between epidural and paravertebral during esophagectomy OTHER

The thoracic epidural technique remains the gold standard for perioperative pain management for this procedure. The placement of a paravertebral catheter homolateral with the thoracic incisions is strongly recommended. A goal directed fluid therapy is proposed to guide fluid management and limit postoperative complications. Few studies suggested less side effects in the paravertebral group. The vasoplegia due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to bring more light to the hemodynamic changes caused by two different locoregional techniques. An algorithm for fluid and vasopressor management has been proposed. We defined hypotension as 20% of decrement of the median arterial pressure during anesthesia. To reduce bias, the locoregional techniques is performed by an experienced anesthesiologists and the rest of the perioperative management is conducted by another blinded anesthesiologist.

Epidural group; Paravertebral group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Erasme University Hospital: lead

Related Publications (5)

• 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.

  PMID: 30276441 BACKGROUND

• 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.

  PMID: 34795950 BACKGROUND

• 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.

  PMID: 32087686 BACKGROUND

• 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.

  PMID: 31080659 BACKGROUND

• 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.

  PMID: 26897642 BACKGROUND

Study Officials

• Laszlo SZEGEDI, PHD

  Laszlo.szegedi@hubruxelles.be

  STUDY CHAIR

Central Study Contacts

Annalinda CIORRA, MD

CONTACT

+32(0)25553324; annalinda.ciorra@hubruxelles.be

Fanny BERNARD, MD

CONTACT

+32(0)25553324; fanny.bernard@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-06