Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Pancreatic Diseases; Pancreas Cancer

Treatments: Procedure: Analgesia via epidural catheter; Procedure: Analgesia via wound catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04668781

3169/2018

Details and patient eligibility

About

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.

Full 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).

Enrollment: 92 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Epidural analgesia

Active Comparator group

Treatment:

Procedure: Analgesia via epidural catheter

Wound catheter analgesia

Experimental group

Treatment:

Procedure: Analgesia via wound catheter