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Paravertebral catheter versus Epidural analgesia in Minimally Invasive Esophageal Resection: a randomized controlled multicenter trial (PEPMEN trial)

Paravertebral catheter versus Epidural analgesia in Minimally Invasive Esophageal Resection: a randomized controlled multicenter trial (PEPMEN trial) - PEPMEN trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54619
Enrollment
192
Registered
2019-11-20
Start date
2020-01-21
Completion date
Unknown
Last updated
2025-08-18

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 in patients who undergo minimally invasive esophagectomy.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The study population consists of patients who are scheduled to undergo elective minimally invasive esophagectomy with two-field lymphadenectomy, gastric conduit reconstruction, and intrathoracic anastomosis (i.e. Ivor Lewis procedure).

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 - Ongoing opioid use (i.e. any opioid) prior to esophagectomy (i.e. >3 months calculated until the day of esophagectomy) - Renal failure, i.e. eGFR

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the quality of recovery on postoperative day 3, measured by the *Quality of Recovery - 40 (QoR-40)* questionnaire.

Secondary

MeasureTime frame
Secondary outcome measures include the need for escape pain medication, additional opioid consumption, technical complications, length of intensive care and hospital stay, postoperative complications, quality of life at 3 and 6 months after surgery, pain at 6 months after surgery, and cost-effectiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)