Nausea, Postoperative, Opioid Use, Pain, Postoperative, Surgery
Conditions
Keywords
postoperative analgesia, knee surgery, intravenous lidocaine
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.
Interventions
Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).
DRUGPlacebo
Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The medicine used for each individual patient will be prepared by the nurse not otherwise involved in patient data collection.
Intervention model description
Group A receives linisol 2%, group B receives placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score for pain | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of Nausea and vomiting | from moment of surgery until hospital discharge. on average 8 hours after surgery | Incidence of postoperative nausea and vomiting |
| PONV treatment | from moment of surgery until hospital discharge. on average 8 hours after surgery | Number of pharmacological treatments for Postoperative Nausea & Vomiting (PONV) |
| opioid use | at the PACU on average 60 minutes | dosing and frequency of opioid use |
| length of stay at the PACU | 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 |
| general patient comfort | 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. |
Countries
Belgium
Outcome results
None listed