Effects of Different Doses of Intravenous Lidocaine Infusion on Peri-operative Pain and Incidence of Postoperative Chronic Pain Within ERAS Protocols, a Dose Finding Study.

NCT06431165 | Recruiting Phase 1

• 1 other identifier: Pain management
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed To investigate the effects of different doses of Intraoperative intravenous lidocaine infusion on intraoperative opioid consumption, perioperative pain control and incidence of postoperative chronic pain.

Conditions

Perioperative Pain Management

Outcome Measures

Primary Outcomes (1)

• Total Intraoperative opioid consumption (Fentanyl)

  Fentanyl doses of 0.5 mic/kg will be given when there is increase in hemodynamics by 20% of baseline and this will be reported

  Every five minutes

Secondary Outcomes (4)

• Total opioid consumption (Morphine) in the first 24 hours postoperative.

  Every one hour postoperative for 24 hours

• Time of first rescue analgesia used in the first 24 hours postoperative

  Every one hour postoperative for 24 hours

• Incidence of side effects related to Lidocaine infusion during the first 24 hours postoperative.

  Every one hour postoperative for 24 hours

• Incidence of chronic postoperative pain 2 months after the surgery.

  Every week for 2 months postoperative.

Study Arms (3)

Group A

ACTIVE COMPARATOR

Group A: Bolus 10 ml Syringe with Lidocaine 0.5% (2.5 ml lidocaine 2% + 7.5 ml N.S), and infusion 50 ml Syringe with Lidocaine 0.5% (12.5 ml Lidocaine 2% + 37.5 ml N.S).

Drug: Lidocaine IV

Group B

ACTIVE COMPARATOR

Group B: Bolus 10 ml Syringe with Lidocaine 1% (5 ml lidocaine 2% + 5 ml N.S), and infusion 50 ml Syringe with Lidocaine 1% (25 ml Lidocaine 2% + 25 ml N.S).

Drug: Lidocaine IV

Group C

ACTIVE COMPARATOR

Group C: Bolus 10 ml Syringe with plain Lidocaine 2%, and infusion 50 ml Syringe with plain Lidocaine 2%.

Drug: Lidocaine IV

Interventions

Lidocaine IV DRUG

After confirming patient history, type of operation and patient group allocation, standard ASA monitoring will be attached to the patient then the I.V induction of anesthesia will be commenced using standard doses of Propofol \&Tracrium in addition to 1 μg/kg Fentanyl and 1 ml/10 kg from the bolus Lidocaine syringe followed after 3 minutes by endotracheal intubation, then the Lidocaine infusion Syringe will be attached to a separate I.V line at an infusion rate of 1 ml/10 kg/h. The patient will receive 1 gm of I.V paracetamol and the surgery will be allowed to proceed.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age between 18 and 65.
• Patients with ASA I and II status.
• Patients undergoing open laparotomy surgeries (including open cholecystectomies).

You may not qualify if:

• Patients unable to comprehend the informed consent.
• Patients on long term pre-operative opioid regimens.
• Patients with impairment in hepatic or renal functions.
• Patients who are planned to receive any form of regional block for the surgery.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 1111, Egypt

RECRUITING

Study Officials

• Mohammed Ahmed Mansour, Assistant professor

  Cairo University

  STUDY DIRECTOR

• Islam Ayman Mohammed Shawky, MD

  Cairo University

  STUDY DIRECTOR

• Nora Amr Agiza, MD

  Cairo University

  STUDY DIRECTOR

• Omnia Y Kamel, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Alaa Magdy Ahmed Hassan, Master

CONTACT

01090282616; loka272@yahoo.com

Amany Ezzat Ayad Ibrahim, Professor

CONTACT

01223429325; amanymounir@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Each patient will be assigned by a randomly computer generated number to one of the 3 groups and the group assignment will be put in a sealed envelope only accessible by the investigator responsible for preparing the drug syringes. The patient and data collectors will be blinded to the patient group allocation as well as the managing anesthiologists during the operation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology and surgical ICU and pain management

Model Details: A prospective randomized controlled double blinded study

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: March 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)