Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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 get additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).

Official Title
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Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Conditions
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Pancreatic Diseases, Pancreas Cancer

Intervention / Treatment
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* Procedure: Analgesia via epidural catheter
* Procedure: Analgesia via wound catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or over patients who undergo pancreaticoduodenectomy without vascular recostruction Exclusion Criteria: patients to whom are made a vascular reconstruction patients who have significantly elevated risk for complications 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural analgesia<br> | Procedure: Analgesia via epidural catheter<br>* 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.<br>|
| Experimental: Wound catheter analgesia<br> | Procedure: Analgesia via wound catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid volume intraoperatively and postoperatively | The amount of fluid (crystalloids and albumin) patients have got during the surgery and postoperatively (ml/kg). | postoperative day 0-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of used norepinephrine | The amount of norepinephrine patients have got intraoperatively and postoperatively (mg/kg). | postoperative day 0-7 | 
| Total dose of oxycodone | The amount of oxycodone patients have dosed via i.v. PCA pump (mg). | postoperative day 0-7 | 
| Hospital length of stay |  | postoperative day 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). | postoperative day 0-30 | 
| Reoperation rates |  | postoperative day 0-30 | 
| Readmission rates |  | postoperative day 0-30 | 
| Mortality |  | postoperative day 0-90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, fluid therapy, enhanced recovery after surgery (ERAS), postoperative complications