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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22504
Enrollment
192
Registered
2019-09-19
Start date
2019-12-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Paravertebral catheter analgesia combined with patient-controlled intravenous opioids.

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: - ASA >III / severe comorbidity - Coagulation disorders that prohibit epidural analgesia according to the Nederlandse Vereniging voor Anesthesiologie (NVA) guideline “Neuraxisblokkade en antistolling” - 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Contacts

Public ContactFeike Kingma

University Medical Center Utrecht

b.f.kingma-2@umcutrecht.nl+31 88 75 569 72

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)