Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

NCT04668781 | Completed

• 1 other identifier: 3169/2018
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Diseases; Pancreas Cancer

Keywords

pancreaticoduodenectomy; fluid therapy; enhanced recovery after surgery (ERAS); postoperative complications

Outcome Measures

Primary Outcomes (1)

• The norepinephrine consumption

  Norepinephrine consumption on POD 0

  Postoperative day 0

Secondary Outcomes (7)

• Fluid volumes on PODs 0-4

  Postoperative days 0-4

• Oxycodone consumption

  Postoperative days 1-4

• Hospital length of stay

  Postoperative days 0-60

• Postoperative complications

  Postoperative days 0-90

• Reoperation rates

  Postoperative days 0-90

Study Arms (2)

Epidural analgesia

ACTIVE COMPARATOR

Procedure: Analgesia via epidural catheter

Wound catheter analgesia

EXPERIMENTAL

Procedure: Analgesia via wound catheter

Interventions

Analgesia via epidural catheter PROCEDURE

Ropivacain-infusion 2 mg/ml 1,25ml/h/10kg IBW (ideal body weight) is started to patients in the beginning of the surgery and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Epidural analgesia

Analgesia via wound catheter PROCEDURE

Ropivacain 5 mg/ml 2,5ml/10kg IBW (ideal body weight) is given to patients in the end of the surgery. After that ropivacain-infusion 2mg/ml 1,25ml/h/10kg IBW is started to patients and is continued to POD 4. The rest of the treatment obey study protocol in both groups.

Wound catheter analgesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or over
• patients who undergo pancreaticoduodenectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, HUS, 00029, Finland

Location

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatic Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal Investigator

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: December 21, 2020
• Primary Completion: September 18, 2024
• Study Completion: December 18, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)