Pancreas Cancer, Pancreatic Diseases
Conditions
Keywords
pancreaticoduodenectomy, fluid therapy, enhanced recovery after surgery (ERAS), postoperative complications
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).
Interventions
PROCEDUREAnalgesia via epidural catheter
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.
PROCEDUREAnalgesia via wound catheter
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.
Sponsors
University of Helsinki
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The norepinephrine consumption | Postoperative day 0 | Norepinephrine consumption on POD 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Fluid volumes on PODs 0-4 | Postoperative days 0-4 | Intraoperative and postoperative fluid volumes |
| Readmission rates | Postoperative days 0-90 | — |
| Mortality | postoperative day 0-90 | — |
| Reoperation rates | Postoperative days 0-90 | — |
Countries
Finland
Outcome results
None listed