Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04668781

Collaborator

University of Helsinki (Other)

100

Enrollment

Location

Arms

48.3

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Diseases Pancreas Cancer	Procedure: Analgesia via epidural catheter Procedure: Analgesia via wound catheter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Actual Study Start Date :

Dec 21, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Fluid volume intraoperatively and postoperatively [postoperative day 0-7]
The amount of fluid (crystalloids and albumin) patients have got during the surgery and postoperatively (ml/kg).

Secondary Outcome Measures

The amount of used norepinephrine [postoperative day 0-7]
The amount of norepinephrine patients have got intraoperatively and postoperatively (mg/kg).
Total dose of oxycodone [postoperative day 0-7]
The amount of oxycodone patients have dosed via i.v. PCA pump (mg).
Hospital length of stay [postoperative day 0-60]
Postoperative complications [postoperative day 0-30]
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).
Reoperation rates [postoperative day 0-30]
Readmission rates [postoperative day 0-30]
Mortality [postoperative day 0-90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki	HUS	Finland	00029

Sponsors and Collaborators

Helsinki University Central Hospital
University of Helsinki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Piia Peltoniemi, M.D., Principal Investigator, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT04668781

Other Study ID Numbers:

3169/2018

First Posted:

Dec 16, 2020

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Piia Peltoniemi, M.D., Principal Investigator, Helsinki University Central Hospital

pancreaticoduodenectomy

fluid therapy

enhanced recovery after surgery (ERAS)

postoperative complications

Additional relevant MeSH terms:

Pancreatic Neoplasms

Pancreatic Diseases

Study Results

No Results Posted as of Mar 17, 2022