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Cairo UniversityEffects of Different Doses of Intravenous Lidocaine Infusion on Peri-operative Pain and Incidence of Postoperative Chronic Pain Within ERAS Protocols, a Dose Finding Study. Phase 1, Phase 2 69
Clinical Trial NCT06431165 is designed to study Treatment for Perioperative Pain Management. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 15 March 2024, with plans to enroll 69 participants. Led by Cairo University, it is expected to complete by 1 April 2025. The latest data from ClinicalTrials.gov was last updated on 28 May 2024.
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.
Detailed Description
Enhanced recovery after surgery (ERAS) protocols or fast track surgery are a number of interventions which are carried out in the perioperative period. They are aimed to decrease the harmful effects of surgery on the body and help the patient recover better after surgery. ERAS has been shown to reduce the length of hospital stay, overall hospital costs, opioid consumption in the perioperative period and to reduce com...Show More
Official Title
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.
Conditions
Perioperative Pain ManagementOther Study IDs
- Pain management
NCT ID Number
Start Date (Actual)
2024-03-15
Last Update Posted
2024-05-28
Completion Date (Estimated)
2025-04
Enrollment (Estimated)
69
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGroup A 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). | Lidocaine IV 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 attach...Show More |
Active ComparatorGroup B 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). | Lidocaine IV 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 attach...Show More |
Active ComparatorGroup C Group C: Bolus 10 ml Syringe with plain Lidocaine 2%, and infusion 50 ml Syringe with plain Lidocaine 2%. | Lidocaine IV 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 attach...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | Time between end of surgery and the first dose of rescue analgesia administered to the patient | 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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Patients age between 18 and 65.
- Patients with ASA I and II status.
- Patients undergoing open laparotomy surgeries (including open cholecystectomies).
- 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.
Cairo University1117 active studies to exploreStudy Responsible Party
Omnia Yahia El Sayed Kamel, Principal Investigator, Lecturer of anesthesiology and surgical ICU and pain management, Cairo University
Study Central Contact
Contact: Alaa Magdy Ahmed Hassan, Master, 01090282616, [email protected]
Contact: Amany Ezzat Ayad Ibrahim, Professor, 01223429325, [email protected]
1 Study Locations in 1 Countries
Cairo University, Cairo, 1111, Egypt
Omnia Y Kamel, MD, Contact, 01270130326, [email protected]
Recruiting