Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy

Not Applicable

Not yet recruiting

• Conditions: Epidural; Anesthesia; Paravertebral Anesthesia; Esophagectomy; Hemodynamic Instability
• Interventions: Other: Hemodynamic changes between epidural and paravertebral during esophagectomy

• Registration Number: NCT06563557
• Lead Sponsor: Erasme University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural group	Hemodynamic changes between epidural and paravertebral during esophagectomy	-
Paravertebral group	Hemodynamic changes between epidural and paravertebral during esophagectomy	-

Primary Outcome Measures

Name	Time	Method
Consumption of norepinephrine and fluids during procedure	6 hours	norepinephrine mcg/kg/hr

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	6 months	Medical complications: Pneumonia, atrial fibrillation, thromboembolic event Surgical complications : Wound dehiscence, anastomotic leakage, chylothorax, recurrent laryngeal nerve injury