Perioperative Intravenous Lidocaine in Liver Surgery

Study Overview
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Brief Summary
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This is a randomized double blinded placebo-controlled study, conducted in Lund, Sweden. Patients will be randomized in two groups, with a ratio of 1:1. The experimental arm will receive intravenous Lidocaine perioperatively, and the Control arm will receive placebo, i.e. normal Saline. Postoperative both arms will get routine pain Control with PCA, Patient Controlled Analgesia with an intravenous Oxycodone-infusion. Outcome-measures will include patients pain intensity scoring, and opioid consumption.

Detailed Description
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Patientes will be randozied in blocks of eight. The experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. The placebo arm will receive the same amount of normal Saline instead. Pain intensity scoring, measured by Numerical Rating Scale, NRS, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 Days.

Official Title
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Intravenous Lidocaine for Postoperative Recovery in Liver Surgery, a Randomized Double Blinded Placebo-controlled Study

Conditions
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Postoperative Pain, Liver Metastases, Liver Cancer, Opioid Use

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 yy Patient planned for minor hepatectomy Signed informed consent Exclusion Criteria: Pregnancy Cirrosis ASA>3 Elevated liver enzymes AV-block >1, without pacemaker WHO class >2 Allergy against Lidocain or other amid-type local anasthesia Heart failure Epilepsy Treatment with class III anti-arythimic medication Preoperative ongoing opioid usage Use of : Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, ciprofloxacin, antivirala-HIV-läkemedel or imidazol the week before surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double blinded placebo-controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine arm<br>The experimental arm will receive a bolus of 1,5mg/kg Lidocaine before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. | Drug: Lidocaine<br>* Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery<br>|
| Placebo Comparator: Placebo arm<br>The placebo arm will receive the same amount of normal Saline. | Drug: Normal saline<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption at 24 hours | Sum of opioids consumed | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption at 48 hours | Sum of opioids consumed | 48 hours postoperatively | 
| Opioid consumption at 72 hours | Sum of opioids consumed | 72 hours postoperatively | 
| Opioid consumption at 96 hours | Sum of opioids consumed | 96 hours postoperatively | 
| Opioid consumption at 120 hours | Sum of opioids consumed | 120 hours postoperatively | 
| Postoperative pain intensity | Numerical rating scale (NRS) in rest and activity, scale 0-10, 0=no pain, 10=worst imaginable pain | Day 0-5 postoperatively, twice every day | 
| Number of participants with Postoperative comlications | Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5 | 30 days postoperatively | 
| Level of Postoperative comlications | Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4a,4b,5, 0 beeing none and 5 beeng death. | 30 days postoperatively | 
| Time to return of Bowel function | Time to first flatus and defacation | Day 0-30 postoperatively | 
| Number of participants with Postoperative nausea and vomiting | Postoperative nausea and vomiting, as noted in questionary Quality of recovery-40 | Day 1-5 postopertively | 
| Level of Postoperative nausea and vomiting | Postoperative nausea and vomiting, as noted in questionary Quality of recovery-40 | Day 1-5 postopertively | 
| Days in hospital | Length of hospital stay | 0-90 days postoperatively | 
| Level of MEGX concentrations | Concentration of the metabolite MEGX in patients blood | Twice during surgery, and once 1 hour after surgery. | 
| Level of Lidocaine concentration | Concentration of Lidocaine in patients blood | Twice during surgery, and once 1 hour after surgery. | 
| Mortality | death after surgery | 30 days postoperatively | 
| Rating of Quality of recovery-40 | Quality of recovery questionary. | Day 1-5 postoperatively | 
| Number of participant with Adverse Events | All adverse events | 0-30 days | 
| Level of adverse events | All adverse events, classified according to CTCEA | 0-30 days | 
| Number of participants with Chronic Postsurgical pain | Chronic Postsurgical pain, according to Brief Pain inventory- questionary | 3 months after surgery | 
| Level of Chronic Postsurgical pain | Chronic Postsurgical pain, according to Brief Pain inventory- questionary | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver surgery, postoperative pain, Lidocaine, opioid use