Intravenous vs. epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy

Not Applicable

• Conditions: C25; Malignant neoplasm of pancreas

• Registration Number: DRKS00007784
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-23
• Study Completion: 2017-09-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 371

Inclusion Criteria

Patients scheduled for elective pancreatoduodenectomy
- Age = 18 years
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent

Exclusion Criteria

- Chronic pancreatitis
- Severe COPD (Stage III according to GOLD criteria)
- American Society of Anesthesiologists (ASA) physical status classification = IV
- Patients with chronic pain syndrome due to any reason
- Presence of contraindication(s) to the use of patient-controlled intravenous analgesia or epidural analgesia
- Participation in another intervention-trial with interference of intervention and outcome of this study
- Language problems

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined endpoint of gastrointestinal complications (Delayed gastric emptying, pancreatic fistula, biliary leak, gastrointestinal bleeding, postoperative ileus) until postoperative day 30.<br>

Secondary Outcome Measures

Name	Time	Method
- Delayed gastric emptying<br>- Pancreatic fistula<br>- Biliary leak<br>- Gastrointestinal bleeding<br>- Postoperative ileus<br>- Combined endpoint of infectious complications (pneumonia, urinary tract infection, wound infection intraabdominal abscess, sepsis)<br>- Hospital stay / ICU stay / readmission until postoperative day 30<br>- Mortality <br>- Morbidity until postoperative day 30<br>- Frequency of blood transfusions<br>- Amount of given vasopressors during operation<br>- Pain control with numeric rating scale (NRS)<br>- Amount of given fluids<br>- Weight over time/weight changes<br>- SAE