Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431165
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief 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
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-26-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 085 Lkgh 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 24 06 μgmL while side effects as - have been reported when the plasma concentration was higher than 5-8 μgmL The suggested dosing regimens mentioned in literature to achieve this effective plasma level while avoiding toxicity is a bolus of 1-2 mgkg at surgery start followed by infusion of 1-2 mgkgh 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
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-26-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 085 Lkgh 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 24 06 μgmL while side effects as - have been reported when the plasma concentration was higher than 5-8 μgmL The suggested dosing regimens mentioned in literature to achieve this effective plasma level while avoiding toxicity is a bolus of 1-2 mgkg at surgery start followed by infusion of 1-2 mgkgh 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None