Clinical trial NCT03599427: Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee Arthroscopy
Official title: Added Value of Systemic Lidocaine in Combination With Local Infiltration Analgesia for Knee Arthroscopic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Pain, Postoperative
Nausea, Postoperative
Opioid Use
Keywords: postoperative analgesia
knee surgery
intravenous lidocaine
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A receives linisol 2%, group B receives placebo.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Visual Analog Score for pain
timeFrame: from moment of surgery until hospital discharge. on average 8 hours after surgery
Secondary outcomes:
measure: incidence of Nausea and vomiting
timeFrame: from moment of surgery until hospital discharge. on average 8 hours after surgery
measure: PONV treatment
timeFrame: from moment of surgery until hospital discharge. on average 8 hours after surgery
measure: opioid use
timeFrame: at the PACU on average 60 minutes
measure: length of stay at the PACU
timeFrame: from moment of surgery until discharge from the PACU. on average 60 minutes after surgery
measure: general patient comfort
timeFrame: at the moment before of hospital discharge. on average 8 hours after surgery.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost
Study officials:
affiliation: Maria Middelares Hospital
name: Alain F Kalmar, MD,PhD,MSc
role: PRINCIPAL_INVESTIGATOR
References: