Sufficient analgesia with patient-controlled analgesia compared to epidural anaesthesia in patients after robotic assisted minimal invasive esophagectomy (RAMIE)

• Conditions: C15; Malignant neoplasm of oesophagus

• Registration Number: DRKS00019220
• Lead Sponsor: Klinik für Anästhesiologie Universitätsmedizin Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-10-17
• Study Start: 2019-11-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

age = 18 years
no enrollment in other clinical study
person capable of giving consent
elective RAMIE surgery

Exclusion Criteria

age < 18 years
missing consent
inability of giving consent
ASA = 4
Premedication with opioids
Patients with a chronic pain syndrome
Patients with a diagnosed polyneuropathy
Patients with a diagnosed psychic disorder
Simultaneous enrollment in another clinical study

Patients with contraindications for EDA will receive no EDA

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative quality of analgesia regarding NRS/VAS at rest and while moving<br><br>Postoperative amount of analgesics<br><br>Use of co-analgesics<br><br>Duration of postoperative analgesia

Secondary Outcome Measures

Name	Time	Method
Intraoperative use of analgesia<br><br>Ventilation parameters (peak pressure, compliance)<br><br>Single-lung ventilation (SLV) (duration, need of additional cpap)<br><br>duration of surgery and ventilation<br><br>blood gas tests (awake, start of surgery, before single-lung-ventilation, after 10min of SLV, before end of surgery)<br><br>duration of hospital stay<br><br>first physiotherapeutic treatment possible<br><br>RASS and NRS for nausea and vomiting <br><br>FEV1 before and after surgery<br><br>postoperative complications (re-admission icu, pneumonia, sepsis, anastomotic insufficiency)