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Clinical Trials/NCT03599427
NCT03599427
Completed
Phase 4

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

Algemeen Ziekenhuis Maria Middelares1 site in 1 country60 target enrollmentSeptember 1, 2018

Overview

Phase
Phase 4
Intervention
systemic lidocaine
Conditions
Surgery
Sponsor
Algemeen Ziekenhuis Maria Middelares
Enrollment
60
Locations
1
Primary Endpoint
Visual Analog Score for pain
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
June 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Algemeen Ziekenhuis Maria Middelares
Responsible Party
Principal Investigator
Principal Investigator

Dr. Alain Kalmar, MD, PhD

Staff Anesthesist

Algemeen Ziekenhuis Maria Middelares

Eligibility 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

Arms & Interventions

systemic lidocaine

Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery.

Intervention: systemic lidocaine

Placebo

Saline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery.

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

  • incidence of Nausea and vomiting(from moment of surgery until hospital discharge. on average 8 hours after surgery)
  • PONV treatment(from moment of surgery until hospital discharge. on average 8 hours after surgery)
  • opioid use(at the PACU on average 60 minutes)
  • length of stay at the PACU(from moment of surgery until discharge from the PACU. on average 60 minutes after surgery)
  • general patient comfort(at the moment before of hospital discharge. on average 8 hours after surgery.)

Study Sites (1)

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