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NCT Number: NCT04668781

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.

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Key information

Conditions

Pancreatic Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreas Cancer Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, HUS, 00029, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analgesia via epidural catheter

Procedure

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.

Analgesia via wound catheter

Procedure

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.

Primary outcomes

  1. The norepinephrine consumption

    Time frame: Postoperative day 0

    Norepinephrine consumption on POD 0

Secondary outcomes

  1. Fluid volumes on PODs 0-4

    Time frame: Postoperative days 0-4

    Intraoperative and postoperative fluid volumes

  2. Oxycodone consumption

    Time frame: Postoperative days 1-4

    Intravenous PCA opioid consumption.

  3. Hospital length of stay

    Time frame: Postoperative days 0-60

  4. Postoperative complications

    Time frame: 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).

  5. Reoperation rates

    Time frame: Postoperative days 0-90

  6. Readmission rates

    Time frame: Postoperative days 0-90

  7. Mortality

    Time frame: postoperative day 0-90

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2020
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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