Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Helsinki University Central Hospital92 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Diseases Pancreas Cancer

Interventions

Analgesia via epidural catheterPROCEDURE

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.

Analgesia via wound catheterPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Hospital

Helsinki, HUS, Finland

Outcomes

Primary Outcomes

The norepinephrine consumption

Norepinephrine consumption on POD 0

Time frame: Postoperative day 0

Secondary Outcomes

Fluid volumes on PODs 0-4

Intraoperative and postoperative fluid volumes

Time frame: Postoperative days 0-4

Oxycodone consumption

Intravenous PCA opioid consumption.

Time frame: Postoperative days 1-4

Hospital length of stay

Time frame: Postoperative days 0-60

Postoperative complications

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).

Time frame: Postoperative days 0-90

Reoperation rates

Time frame: Postoperative days 0-90

Readmission rates

Time frame: Postoperative days 0-90

Mortality

Time frame: postoperative day 0-90

Data from ClinicalTrials.gov

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