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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Surgery; Opioid Use; Nausea, Postoperative
• Intervention / Treatment: Drug: systemic lidocaine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Oost
    • Gent, Oost, Belgium, 9000
      • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: saline 0.9%

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Alain F Kalmar, MD,PhD,MSc, Maria Middelares Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: knee surgery; postoperative analgesia; intravenous lidocaine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Vomiting; Pain, Postoperative; Nausea; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: MMS.2017.032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No