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

Algemeen Ziekenhuis Maria Middelares

Status and phase: Completed; Phase 4

Conditions: Surgery; Pain, Postoperative; Opioid Use; Nausea, Postoperative

Treatments: Drug: Placebo; Drug: systemic lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03599427

MMS.2017.032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

systemic lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: systemic lidocaine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo