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NCT Number: NCT03599427

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

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.

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Key information

Conditions

Surgery Nausea Nausea, Postoperative Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AZ Maria Middelares

Ghent, Oost, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

systemic lidocaine

Drug

Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).

Other names: linisol 2%

Placebo

Drug

Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)

Other names: saline 0.9%

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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