Intercostal catheter (ICC) versus thoracic epidural analgesia (TEA) for pain management after robot-assisted minimally invasive esophagectomy (RAMIE)

Intercostal catheter (ICC) versus thoracic epidural analgesia (TEA) for pain management after robot-assisted minimally invasive esophagectomy (RAMIE) - DaVICC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022968

Enrollment

100

Registered

2020-08-31

Start date

2020-08-24

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

C15

Interventions

Group 1: Intercostal catheter - positioned intraoperatively - Ropivacaine 0,375% infusion rate 6-8ml/h - co-medicatioon metamizole 5g/24h iv. Group 2: Thoracic epidural analgesia - positioned preopera

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. = 18 years pf age 2. ability to give written consent 3. elective RAMIE as a treatment for esophageal cancer 4. written informed consent 5. no simultaneous participation in another study which influences outcome parameters

Exclusion criteria

Exclusion criteria: 1. age =18 years 2. chronic pain syndrome 3. preoperative use of opioids 4. polyneuropathy 5. psychological disorders e.g. depression 6. ASA status =4 7. simultaneous participation in another study which influences outcome parameters 8. inability to give written consent 9. pregnancy 10. emergency patients

Design outcomes

Primary

Measure	Time frame
comparison of postoperative quality of analgesia between intercostal catheter and thoracic epidural analgesia after RAMIE evaluating 1. numeric rating scale (NRS) at rest, arm movement, mobilization to bed side and during deep inspiration/coughing 2. total dosage of analgesic medication 3. total dosage of co-analgesic medication 4. total duration of postoperative pain therapy	—

Secondary

Measure	Time frame
comparison in aspect to: 1. time to first mobilization 2. duration of hospital stay and days spent on intensive care unit (ICU) common side effects: 1. sedation via Richmond Agitatation and Sedation Score (RASS) 2. nausea (NRS) 3.Vomiting (NRS) 4. lung capacity pre-and postoprative measurement of forced one second capacity (FEV1) postoperative complications: 1. readmission on ICU, 2. Pulmonary complications (Re-intubation, pathogen in sputum, pneumonia), 3. sepsis, 4. insufficiency of anastomosis	—

Measure

Time frame

comparison in aspect to: 1. time to first mobilization 2. duration of hospital stay and days spent on intensive care unit (ICU) common side effects: 1. sedation via Richmond Agitatation and Sedation Score (RASS) 2. nausea (NRS) 3.Vomiting (NRS) 4. lung capacity pre-and postoprative measurement of forced one second capacity (FEV1) postoperative complications: 1. readmission on ICU, 2. Pulmonary complications (Re-intubation, pathogen in sputum, pneumonia), 3. sepsis, 4. insufficiency of anastomosis

—

Countries

Germany

Contacts

Public ContactSusanne Fischer

Universitätsmedizin MainzKlinisches Studienzentrum Anästhesiologie

susanne.fischer@unimedizin-mainz.de06131177175

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026