Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreas Cancer; Pancreatic Diseases
• Interventions: Procedure: Analgesia via epidural catheter; Procedure: Analgesia via wound catheter

• Registration Number: NCT04668781
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

The study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. The aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.

Detailed Description

All patients undergoing pancreaticoduodenectomy in Helsinki University Hospital are recruited in the study. Patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. Both groups receive additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-16
• Study Start: 2020-12-21
• Primary Completion: 2024-09-18
• Study Completion: 2024-12-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age 18 years or over
• patients who undergo pancreaticoduodenectomy

Exclusion Criteria

• patients to whom are made a major vascular reconstruction
• patients with significant comorbidities and inability to use PCA
• regural use of strong opioids or drugs preoperatively
• patients with severe chronic pain issues
• chronic atrial fibrillation
• patients who refuse to take part to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural analgesia	Analgesia via epidural catheter	-
Wound catheter analgesia	Analgesia via wound catheter	-

Primary Outcome Measures

Name	Time	Method
The norepinephrine consumption	Postoperative day 0	Norepinephrine consumption on POD 0

Secondary Outcome Measures

Name	Time	Method
Fluid volumes on PODs 0-4	Postoperative days 0-4	Intraoperative and postoperative fluid volumes
Oxycodone consumption	Postoperative days 1-4	Intravenous PCA opioid consumption.
Hospital length of stay	Postoperative days 0-60
Postoperative complications	Postoperative days 0-90	Clavien-Dindo complications (scale 0-5), pancreatic fistulas (ISGPF definition, grade A-C), postpancreatectomy hemorrage (IPGPS definition, grade A-C), delayed gastric emptying (ISGPS definition, grade A-C).
Reoperation rates	Postoperative days 0-90
Readmission rates	Postoperative days 0-90
Mortality	postoperative day 0-90

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, HUS, Finland