Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Diseases; Pancreas Cancer
• Intervention / Treatment: Procedure: Analgesia via epidural catheter; Procedure: Analgesia via wound catheter

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 get additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piia Peltoniemi, M.D.; Phone Number: +35894711; Email: piia.peltoniemi@hus.fi
• Study Contact Backup: Name: Pertti Pere, Ass.Prof; Phone Number: +35894711; Email: pertti.pere@hus.fi

Study Locations

• Finland
  • HUS
    • Helsinki, HUS, Finland, 00029
      • Recruiting
      • Helsinki University Hospital
      • Contact: Piia Peltoniemi, M.D.; Phone Number: +35894711; Email: piia.peltoniemi@helsinki.fi
      • Contact: Pertti Pere, M.D, docent; Phone Number: +35894711; Email: pertti.pere@hus.fi
      • Principal Investigator: Piia Peltoniemi, M.D.
      • Principal Investigator: Pertti Pere, Ass.Prof
      • Principal Investigator: Hanna Seppänen, Ass.Prof
      • Sub-Investigator: Teija Nieminen, M.D
      • Sub-Investigator: Arto Kokkola, Ass.Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural analgesia	Procedure: Analgesia 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.
Experimental: Wound catheter analgesia	Procedure: Analgesia 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; postoperative complications; fluid therapy; enhanced recovery after surgery (ERAS)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Neoplasms; Pancreatic Diseases
• Other Study ID Numbers: 3169/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No