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

Phase 4

Completed

• Conditions: Surgery; Pain, Postoperative; Nausea, Postoperative; Opioid Use
• Interventions: Drug: Placebo; Drug: systemic lidocaine

• Registration Number: NCT03599427
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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.

Study Timeline

• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Study Start: 2018-09-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery.
systemic lidocaine	systemic lidocaine	Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Gent, Oost, Belgium