Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

Study Overview
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Brief Summary
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Placebo-controlled study to analyze the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .

Detailed Description
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Thoracoscopy (thoracic surgery) is a video-assisted minimally invasive operation in thoracic surgery, which is associated with pain after surgery. Trial drug Lidocaine is approved as pain medication. This placebo-controlled study analyzes the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery . Half of the patients will receive NaCl 0.9% (a saline solution without active ingredient) instead of Lidocaine.

Official Title
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Prospective, Randomized, Double Blind, Superiority Trial, Evaluating the Effect of Perioperative Lidocaine on Postoperative Opioid Consumption, Pain Ratings, Duration of Hospital Stay, Time to First Defecation, 30-day Mortality and Development of Chronic Pain in Patients Undergoing Video-assisted Thoracoscopic Procedures

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: NaCl 0,9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing video-assisted thoracoscopic procedures under general anaesthesia. American Society of Anesthesiologists (ASA) physical Status classes I to III age ≥ 18 years Patient informed consent Exclusion Criteria: Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Contraindications to self-administration of opioids Women who are pregnant or breast feeding Steroid therapy Chronic pain therapy Atrioventricular block grade II to III Congestive heart failure Liver insufficiency Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia Participation in another study with investigational drug within the 30 days preceding and during the present study, Enrolment of the investigator, his/her family members, employees and other dependent persons

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>perioperative IV administration regimen of lidocaine will be as follows: 1.5 mg/kg IV induction bolus dose (before intubation and at least 30 minutes before incision) followed by continuous infusion of 3.mg/kg/h, until 2 hours after skin closure | Drug: Lidocaine<br>* regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h<br>|
| Placebo Comparator: Placebo<br>perioperative IV administration regimen of placebo solution (NaCl 0,9%) will be as follows: induction bolus (before intubation and at least 30 minutes before incision) followed by continuous infusion of placebo solution (NaCl 0,9%) until 2 hours after skin closure | Drug: NaCl 0,9%<br>* IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total morphine consumption (TMC) | change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA) | within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure | 
| change in pain intensity | change in pain intensity of at least 1.5 units on the Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity; the scale is anchored by no pain (score of 0) and worst imaginable pain (score of 100 [100-mm scale]) | within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | length of hospital stay (in days) | from day of surgery until day of discharge from hospital (an average of 2 days) | 
| time to first defecation - Defined as the time from skin closure to the time of first defecation | time to first defecation - Defined as the time from skin closure to the time of time to first defecation (measured in hours) | From timepoint of surgical skin closure (end of surgery) to the timepoint of first defecation after surgical skin closure (an average of 2 days) | 
| Change in chronic pain | Change in pain intensity (with and without coughing) on the Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity; the scale is anchored by no pain (score of 0) and worst imaginable pain (score of 100 [100-mm scale]) | 2 weeks, 3 months and 6 months after surgery | 
| occurrence of nausea and/or vomiting | occurrence of nausea and/or vomiting | from the date of surgery until the date of discharge from hospital (an average of 2 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracoscopic surgery, Perioperative intravenous lidocaine administration, Lidocaine