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
1
Location
2
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. 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

  1. The amount of used norepinephrine [postoperative day 0-7]

    The amount of norepinephrine patients have got intraoperatively and postoperatively (mg/kg).

  2. Total dose of oxycodone [postoperative day 0-7]

    The amount of oxycodone patients have dosed via i.v. PCA pump (mg).

  3. Hospital length of stay [postoperative day 0-60]

  4. 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).

  5. Reoperation rates [postoperative day 0-30]

  6. Readmission rates [postoperative day 0-30]

  7. 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:
No
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

SiteCityStateCountryPostal Code
1Helsinki University HospitalHelsinkiHUSFinland00029

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:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Piia Peltoniemi, M.D., Principal Investigator, Helsinki University Central Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022