Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Pancreas Cancer Clinical Trial

Official title:

Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668781
• Other study ID #: 3169/2018
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Helsinki University Central Hospital
• Contact: Piia Peltoniemi, M.D.
• Phone: +35894711
• Email: piia.peltoniemi[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Diseases
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	HUS

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The amount of used norepinephrine	The amount of norepinephrine patients have got intraoperatively and postoperatively (mg/kg).	postoperative day 0-7
Secondary	Total dose of oxycodone	The amount of oxycodone patients have dosed via i.v. PCA pump (mg).	postoperative day 0-7
Secondary	Hospital length of stay		postoperative day 0-60
Secondary	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
Secondary	Reoperation rates		postoperative day 0-30
Secondary	Readmission rates		postoperative day 0-30
Secondary	Mortality		postoperative day 0-90