Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery

Pancreatic Cancer Clinical Trial

Official title:

Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04449289
• Other study ID #: 43/3.02.2020
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2020
• Source: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
• Contact: Theodor Bot, PhD Student
• Phone: 0040765350176
• Email: theo_bot[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.

As short term endpoints: postoperative complications and resumption of bowel function.

Long term endpoints include: 1 and 3 year recurrence and mortality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosis of pancreatic cancer

• American Society of Anesthesiologists (ASA) risk I - III

Exclusion Criteria:

• chronic pain

• chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids

• contraindications for any of the study medications

• significant psychiatric disorders (major depression, bipolar disorders, schizophrenia, etc.)

• Convulsive disorders requiring medication during the last 2 years

• liver cirrhosis/chronic kidney disease stage IV or V/chronic heart failure class III or IV/ decompensated diabetes

• Corticoid dependent asthma

• Autoimmune disorders

• Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects

• Refusal for study participation

Related Conditions & MeSH terms

• Pancreatic Cancer
• Recurrence

Intervention

Drug:
• Intravenous lidocaine
Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia
• Epidural ropivacaine
Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia

Locations

Country	Name	City	State
Romania	Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1- and 3-years recurrence rate after surgery	Study participants will be contacted by study team via phone or e-mail	3 years
Secondary	1- and 3-years survival after surgery	Study participants will be contacted by study team via phone or e-mail	3 years
Secondary	Lidocaine and ropivacaine concentration		Intraoperatively
Secondary	Complication rate after surgery	Resumption of bowel function, anastomotic leakage or hemorrhage	2 weeks