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

NCT03599427 | Completed Phase 4

• 1 other identifier: MMS.2017.032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

postoperative analgesia; knee surgery; intravenous lidocaine

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score for pain

  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

  from moment of surgery until hospital discharge. on average 8 hours after surgery

Secondary Outcomes (5)

• incidence of Nausea and vomiting

  from moment of surgery until hospital discharge. on average 8 hours after surgery

• PONV treatment

  from moment of surgery until hospital discharge. on average 8 hours after surgery

• opioid use

  at the PACU on average 60 minutes

• length of stay at the PACU

  from moment of surgery until discharge from the PACU. on average 60 minutes after surgery

• general patient comfort

  at the moment before of hospital discharge. on average 8 hours after surgery.

Study Arms (2)

systemic lidocaine

ACTIVE COMPARATOR

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

Drug: systemic lidocaine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

systemic lidocaine DRUG

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

Also known as: linisol 2%

systemic lidocaine

Placebo DRUG

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

Also known as: saline 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent
• patients which are planned for elective knee arthroscopy
• ASA 1 and 2
• knee arthroscopy suitable for intra-articular injection of anesthetics

You may not qualify if:

• contra-indication for lidocaine, paracetamol or diclofenac
• known history of severe post-operative nausea or vomiting
• knee arthroscopy associated with anterior cruciate ligament reconstruction

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, Oost, 9000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Alain F Kalmar, MD,PhD,MSc

  Maria Middelares Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The medicine used for each individual patient will be prepared by the nurse not otherwise involved in patient data collection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesist

Model Details: Group A receives linisol 2%, group B receives placebo.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 30, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

BE (1)