Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee Arthroscopy
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|ClinicalTrials.gov Identifier: NCT03599427|
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : March 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Surgery Pain, Postoperative Nausea, Postoperative Opioid Use||Drug: systemic lidocaine Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Group A receives linisol 2%, group B receives placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The medicine used for each individual patient will be prepared by the nurse not otherwise involved in patient data collection.|
|Primary Purpose:||Supportive Care|
|Official Title:||Added Value of Systemic Lidocaine in Combination With Local Infiltration Analgesia for Knee Arthroscopic Procedures|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
Active Comparator: systemic lidocaine
Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery.
Drug: systemic lidocaine
Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).
Other Name: linisol 2%
Placebo Comparator: Placebo
Saline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery.
Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)
Other Name: saline 0.9%
- Visual Analog Score for pain [ Time Frame: from moment of surgery until hospital discharge. on average 8 hours after surgery ]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
- incidence of Nausea and vomiting [ Time Frame: from moment of surgery until hospital discharge. on average 8 hours after surgery ]Incidence of postoperative nausea and vomiting
- PONV treatment [ Time Frame: from moment of surgery until hospital discharge. on average 8 hours after surgery ]Number of pharmacological treatments for Postoperative Nausea & Vomiting (PONV)
- opioid use [ Time Frame: at the PACU on average 60 minutes ]dosing and frequency of opioid use
- length of stay at the PACU [ Time Frame: from moment of surgery until discharge from the PACU. on average 60 minutes after surgery ]Time (in minutes) between the end of surgery and the discharge from the PACU
- general patient comfort [ Time Frame: at the moment before of hospital discharge. on average 8 hours after surgery. ]VAS for general comfort : from 0 until 100 (0= extremely dissatisfied ; 100= extremely satisfied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599427
|Contact: Alain F Kalmar, MD,PhD,MSc||+32 246 17 email@example.com|
|Contact: Nicky Van Der Vekens, DVM,PhD,MSc||+32 246 17 firstname.lastname@example.org|
|AZ Maria Middelares||Recruiting|
|Gent, Oost, Belgium, 9000|
|Contact: alain f kalmar, MD,MSc, PhD email@example.com|
|Contact: Nicky Vandervekens, MSc,PhD firstname.lastname@example.org|
|Principal Investigator:||Alain F Kalmar, MD,PhD,MSc||Maria Middelares Hospital|