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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00019220

Enrollment

Registered

2019-11-13

Start date

2019-03-18

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C15

Interventions

Group 1: Patients who didn't receive an epidural analgesia preoperatively: Patient-controlled analgesia Intravenous piritramid-PCA, Bolus 1,5mg, blocking time 10min, 4h-maximum: 30mg, study visits on

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Postoperative quality of analgesia regarding NRS/VAS at rest and while moving Postoperative amount of analgesics Use of co-analgesics Duration of postoperative analgesia	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactAnn Kristin Rosner

Klinik für Anästhesiologie Universitätsmedizin Mainz

anrosner@uni-mainz.de015121895006

Outcome results

None listed

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