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

NCT ID: NCT03599427

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

systemic lidocaine

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

Group Type: ACTIVE_COMPARATOR

systemic lidocaine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

systemic lidocaine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

linisol 2%; saline 0.9%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alain Kalmar, MD, PhD

Staff Anesthesist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alain F Kalmar, MD,PhD,MSc

Role: PRINCIPAL_INVESTIGATOR

Maria Middelares Hospital

Locations

AZ Maria Middelares

Ghent, Oost, Belgium

Countries

Belgium

Other Identifiers

MMS.2017.032

Identifier Type: -

Identifier Source: org_study_id