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

Phase 4

Recruiting

Conditions: C15
Malignant neoplasm of oesophagus

Registration Number: DRKS00022968

Lead Sponsor: niversitätsmedizin MainzKlinik für Anästhesiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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