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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.

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.

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06431165
Enrollment
69
Registered
2024-05-28
Start date
2024-03-15
Completion date
2025-04-30
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Pain Management

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 complication rates. One of the most important components of ERAS is adequate perioperative pain control using a multi-modal analgesic approach to help decrease dependence on opioids and provide better recovery and less postoperative hospital stay. Also, the severity and duration of acute postoperative pain is one of the predictors of chronic postsurgical pain (CPSP). Neuroplasticity (spinal sensitization) following the trauma of surgery can transform an acute pain to chronic pain if not treated effectively by aggressive management of acute pain. Lidocaine (or 2-(diethylamino)-N-(2.6-dimethylphenyl) acetamide) is the main prototype of amino-amide local anesthetics. It has analgesic, anti-hyperalgesic and anti-inflammatory properties, which enable its use as a general anesthetic adjuvant. It can reduce nociception, cardiovascular responses to surgical stress, postoperative pain, and analgesic requirements. Accordingly, Lidocaine infusion can have a role in enhancing postoperative quality of recovery, decreasing incidence of chronic postoperative pain and even increasing overall survival in patients undergoing major surgeries like in pancreatectomy. The Systemic effects of intravenous Lidocaine infusion depends on its plasma level which is affected by the rate and dose of administration, drug interactions and speed of metabolism and elimination. Around 90% of lidocaine undergoes hepatic metabolism (CYP3A4), with the production of active metabolites. During lidocaine continuous infusion, the accumulation of these metabolites may inhibit its biotransformation and might be involved in some cases of intoxication. The clearance rate of lidocaine is approximately 0.85 L/kg/h. Finally, lidocaine is eliminated by the kidney (10% of lidocaine is eliminated unchanged in the urine). The target plasma concentrations for Lidocaine for providing effective analgesia is 2.4 ± 0.6 μg/mL, while side effects as - have been reported when the plasma concentration was higher than 5-8 μg/mL. The suggested dosing regimens mentioned in literature to achieve this effective plasma level while avoiding toxicity is a bolus of 1-2 mg/kg at surgery start followed by infusion of 1-2 mg/kg/h over the duration of the surgery which is a relatively wide range, specially, considering the wide variability in type and duration of surgeries, demographics, physical and medical status of patients and type of anesthetic agents and drugs used which all can affect Lidocaine activity, elimination & toxicity. To the best of our knowledge, no evidence exist in the literature that can point towards the ideal dosing regimen for intravenous Lidocaine infusion that can achieve the desired valuable clinical effects while decreasing the incidence of adverse side effects among the wide variety of surgeries and patients encountered within ERAS protocols.

Interventions

DRUGLidocaine 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 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

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

Intervention model description

A prospective randomized controlled double blinded study

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Total Intraoperative opioid consumption (Fentanyl)Every five minutesFentanyl doses of 0.5 mic/kg will be given when there is increase in hemodynamics by 20% of baseline and this will be reported

Secondary

MeasureTime frameDescription
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 postoperativeEvery one hour postoperative for 24 hoursTime between end of surgery and the first dose of rescue analgesia administered to the patient
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.

Countries

Egypt

Contacts

Primary ContactAlaa Magdy Ahmed Hassan, Master
loka272@yahoo.com01090282616
Backup ContactAmany Ezzat Ayad Ibrahim, Professor
amanymounir@kasralainy.edu.eg01223429325

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026