Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee Arthroscopy

Study Overview
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Brief Summary
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Local intra-articular injection of anesthetics (LIA) is increasingly used during knee arthroscopy for pain relief. The LIA can only be performed at the end of surgery as the knee joint is continuously flushed during the arthroscopy. As a consequence, an optimal analgesic effect is only obtained one hour after surgery and opiates are typically used as pain relief in the immediate postoperative period. Since these opiates have a number of side effects such as nausea, vomiting and drowsiness, other analgetic methods are desirable. Intravenous administration of lidocaine, a safe, inexpensive analgesic, is already used in major (abdominal) surgeries and might also be a promising method for pain relief in the first hour after knee arthroscopy, in anticipation of the onset of the analgesic effect of the LIA. The aim of this study is to verify if systemic administration of lidocaine has a beneficial effect on the pain immediately after knee arthroscopy. In addition, the effect of systemic lidocaine administration on postoperative nausea, vomiting and general patient comfort will be evaluated.

Detailed Description
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2X30 patients which are planned for elective knee arthroscopy are randomised: Lidocaine-group and Placebo-group. All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics paracetamol & diclofenac, the patient is administered either linisol 2% (1.5 mg/kg) or placebo NaCl 0.9% (0.075 ml/kg = equivalent volume). At the end of the procedure, linisol or placebo is readministered at the same dose. The surgeon and anesthesiologist are blinded for patient allocation. Postoperative analgesic consumption, nausea and vomiting (PONV), general comfort and pain scores are recorded. Visual Analogue scores (VAS) for knee pain are assessed before surgery, 1-15 minutes after awakening, at the moment of discharge from the post-anesthesia care unit (PACU) and at hospital discharge.

Official Title
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Added Value of Systemic Lidocaine in Combination With Local Infiltration Analgesia for Knee Arthroscopic Procedures

Conditions
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Surgery, Pain, Postoperative, Nausea, Postoperative, Opioid Use

Intervention / Treatment
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* Drug: systemic lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent patients which are planned for elective knee arthroscopy ASA 1 and 2 knee arthroscopy suitable for intra-articular injection of anesthetics Exclusion Criteria: contra-indication for lidocaine, paracetamol or diclofenac known history of severe post-operative nausea or vomiting knee arthroscopy associated with anterior cruciate ligament reconstruction

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A receives linisol 2%, group B receives placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: systemic lidocaine<br>Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery. | Drug: systemic lidocaine<br>* Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).<br>* Other names: linisol 2%;|
| Placebo Comparator: Placebo<br>Saline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery. | Drug: Placebo<br>* Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)<br>* Other names: saline 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score for pain | Pain intensity using the VAS, where 0 = no pain and 100 = pain as bad as can be) before surgery, 1-15 minutes after awakening, at discharge from the PACU and from the hospital | from moment of surgery until hospital discharge. on average 8 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Nausea and vomiting | Incidence of postoperative nausea and vomiting | from moment of surgery until hospital discharge. on average 8 hours after surgery | 
| PONV treatment | Number of pharmacological treatments for Postoperative Nausea & Vomiting (PONV) | from moment of surgery until hospital discharge. on average 8 hours after surgery | 
| opioid use | dosing and frequency of opioid use | at the PACU on average 60 minutes | 
| length of stay at the PACU | Time (in minutes) between the end of surgery and the discharge from the PACU | from moment of surgery until discharge from the PACU. on average 60 minutes after surgery | 
| general patient comfort | VAS for general comfort : from 0 until 100 (0= extremely dissatisfied ; 100= extremely satisfied. | at the moment before of hospital discharge. on average 8 hours after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative analgesia, knee surgery, intravenous lidocaine