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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007784

Enrollment

370

Registered

2015-03-23

Start date

2015-06-30

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

C25

Interventions

Group 1: Intraoperative general anesthesia and postoperative patient-controlled intravenous analgesia (IV-PCA). Group 2: Combined intraoperative general and epidural anesthesia and postoperative epidu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Combined endpoint of gastrointestinal complications (Delayed gastric emptying, pancreatic fistula, biliary leak, gastrointestinal bleeding, postoperative ileus) until postoperative day 30.	—

Secondary

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

Measure

Time frame

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

—

Countries

Austria, Germany, Italy, Slovenia

Contacts

Public ContactPhillip Knebel

Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg 69120 Heidelberg Germany

phillip.knebel@med.uni-heidelberg.de06221-56-6986

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026