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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| systemic lidocaine | Active Comparator | Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery. |
|
| Placebo | Placebo Comparator | Saline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systemic lidocaine | Drug | Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg). |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain F Kalmar, MD,PhD,MSc | Maria Middelares Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Maria Middelares | Ghent | Oost | 9000 | Belgium |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Group A receives linisol 2%, group B receives placebo.
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The medicine used for each individual patient will be prepared by the nurse not otherwise involved in patient data collection.
| Placebo | Drug | Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg) |
|
|
| 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D017670 |
| Sodium Compounds |