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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
Sponsor:
Information provided by (Responsible Party):
Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares

Brief Summary:

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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)
Other Name: saline 0.9%




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. opioid use [ Time Frame: at the PACU on average 60 minutes ]
    dosing and frequency of opioid use

  4. 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

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Alain F Kalmar, MD,PhD,MSc +32 246 17 00 alain.kalmar@gmail.com
Contact: Nicky Van Der Vekens, DVM,PhD,MSc +32 246 17 09 nicky.vandervekens@azmmsj.be

Locations
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Belgium
AZ Maria Middelares Recruiting
Gent, Oost, Belgium, 9000
Contact: alain f kalmar, MD,MSc, PhD       alainkalmar@gmail.com   
Contact: Nicky Vandervekens, MSc,PhD       nicky.vandervekens@azmmsj.be   
Sponsors and Collaborators
Algemeen Ziekenhuis Maria Middelares
Investigators
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Principal Investigator: Alain F Kalmar, MD,PhD,MSc Maria Middelares Hospital

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Responsible Party: Dr. Alain Kalmar, MD, PhD, Staff Anesthesist, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT03599427     History of Changes
Other Study ID Numbers: MMS.2017.032
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares:
postoperative analgesia
knee surgery
intravenous lidocaine

Additional relevant MeSH terms:
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Nausea
Postoperative Nausea and Vomiting
Vomiting
Pain, Postoperative
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action