Lidocaine Infusion With ERAS Protocol for Pancreatic Cancer Surgery: Effect on Pain and Patient Immunity.

NCT05470166 | Completed DMC

• 1 other identifier: lidocaine ERAS whipple
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse. Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress, organ dysfunction, reduction of clinical complications, length of hospital stay and the health costs together with increase of patient satisfaction. lidocaine; it is an amide local anaesthetic Recently its use as intravenous perioperative infusion for abdominal cancer surgeries is encouraging, as it significantly reduces postoperative pain, opioid consumption and nausea and vomiting. it also promotes gastrointestinal function recovery, and shortens the postoperative hospital stay. In addition, lidocaine in particular can act directly and indirectly on pancreatic cancer cells and the tumor microenvironment. The investigators suggest that IV lidocaine infusion in combination with ERAPS protocol may achieve better postoperative outcomes after pancreatic surgery for cancer.

Conditions

ERAS; Lidocaine; Cancer of Pancreas; Natural Killer Cell Cytokine Production

Outcome Measures

Primary Outcomes (1)

• Post-operative nociceptive pain assessment.

  post operative pain assessment using visual analogue scale (VAS), The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be.

  24 hours postoperative

Secondary Outcomes (10)

• Effect on immune response

  pre-operative and 5 days postoperative

• Effect on i tumor recurrence

  pre-operative and 5 days postoperative

• Total intra-operative fluid requirements.

  intra-operative every 10 minutes

• Gastro-intestinal recovery.

  up to 5 days postoperative

• Time to first ambulation

  up to 5 days post-operative

Study Arms (2)

infusion of intraoperative lidocaine to patients undergoing whipple surgery

EXPERIMENTAL

lidocaine 1.5mg/kg infused as bolus, then 2mg/kg/hr through the operation

Drug: Lidocaine IV

saline infusion of same volume of lidocaine

EXPERIMENTAL

same amount of normal saline infused as bolus and infusion

Other: saline IV

Interventions

Lidocaine IV DRUG

lidocaine infusion as bolus 1.5mg/kg then 2mg/kg/hr

infusion of intraoperative lidocaine to patients undergoing whipple surgery

saline IV OTHER

saline infusion same volume as lidocaine

saline infusion of same volume of lidocaine

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-70 years
• Both sex.
• American society of anesthesiology (ASA) physical status class II;III.
• Resectable pancreatic tumors.

You may not qualify if:

• Patients with history of sensitivity to lidocaine,
• Diabetic patients.
• Body weight loss \> 15%.
• Opioid tolerant patient or patient receiving nonsteroidal anti-inflammatory drugs within 1 week of surgery or antiarrythmic drugs.
• Cognitive dysfunction.
• Any history of antitumor treatments or chemotherapy before surgery
• Any contraindication for neuraxial anaesthesia.

Sponsors & Collaborators

• Alexandria University: lead
• University of Alexandria: collaborator

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: July 22, 2022
• Study Start: April 20, 2022
• Primary Completion: January 17, 2024
• Study Completion: April 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months up to 1 year
• Access Criteria: Lidocaine ERAS whipple surgery patient immunity

Locations

EG (1)