Paravertebral catheter versus epidural analgesia in minimally invasive esophageal resection: a randomized controlled multicenter trial

Recruiting

Conditions: Esophageal cancer

Registration Number: NL-OMON22504

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 192

Inclusion Criteria

Patients who are older than 18 years old, able to provide written informed consent, and scheduled to undergo minimally invasive esophagectomy with an intrathoracic anastomosis and two-field lymphadenectomy (Ivor Lewis procedure) will be included.

Exclusion Criteria

-ASA >III / severe comorbidity
-Coagulation disorders that prohibit epidural analgesia according to the Nederlandse Vereniging voor Anesthesiologie (NVA) guideline â€œNeuraxisblokkade en antistollingâ€
-Other contraindications for epidural analgesia
-Allergy to local anesthetics
-Chronic opioid use prior to esophagectomy (>3 months)
-Renal failure, i.e. eGFR < 50
-Unable to complete questionnaires in the language of the country in which the trial is conducted
-Cervical lymph node dissection (i.e. 3-field lymphadenectomy)
-Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of recovery as measured by the Quality of Recovery 40 (QoR-40) questionnaire on the morning of postoperative day 3.

Secondary Outcome Measures

Name	Time	Method
QoR-40 questionnaire score Area Under the Curve on day 1-3, the integrated pain and systemic opioid score and patient satisfaction and pain experience according to the International Pain Outcomes (IPO) questionnaire, cost-effectivenes, additional rescue medication on day 0-3, opioid consumption on day 0-3, technical failure of the pain treatment, duration of anesthesia time, duration of surgery, total postoperative fluid administration day 0-3, postoperative vasopressor and inotrope use, length of urinary catheter use, length of hospital stay, postoperative complications, chronic pain at six months after surgery, and other adverse effects.