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

Primary Purpose

Surgery, Pain, Postoperative, Nausea, Postoperative

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
systemic lidocaine
Placebo
Sponsored by
Algemeen Ziekenhuis Maria Middelares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgery focused on measuring postoperative analgesia, knee surgery, intravenous lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Maria Middelares

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

systemic lidocaine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

incidence of Nausea and vomiting
Incidence of postoperative nausea and vomiting
PONV treatment
Number of pharmacological treatments for Postoperative Nausea & Vomiting (PONV)
opioid use
dosing and frequency of opioid use
length of stay at the PACU
Time (in minutes) between the end of surgery and the discharge from the PACU
general patient comfort
VAS for general comfort : from 0 until 100 (0= extremely dissatisfied ; 100= extremely satisfied.

Full Information

First Posted
June 21, 2018
Last Updated
October 9, 2019
Sponsor
Algemeen Ziekenhuis Maria Middelares
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1. Study Identification

Unique Protocol Identification Number
NCT03599427
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Algemeen Ziekenhuis Maria Middelares

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Pain, Postoperative, Nausea, Postoperative, Opioid Use
Keywords
postoperative analgesia, knee surgery, intravenous lidocaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Group A receives linisol 2%, group B receives placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The medicine used for each individual patient will be prepared by the nurse not otherwise involved in patient data collection.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
systemic lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
systemic lidocaine
Other Intervention Name(s)
linisol 2%
Intervention Description
Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline 0.9%
Intervention Description
Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)
Primary Outcome Measure Information:
Title
Visual Analog Score for pain
Description
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
Time Frame
from moment of surgery until hospital discharge. on average 8 hours after surgery
Secondary Outcome Measure Information:
Title
incidence of Nausea and vomiting
Description
Incidence of postoperative nausea and vomiting
Time Frame
from moment of surgery until hospital discharge. on average 8 hours after surgery
Title
PONV treatment
Description
Number of pharmacological treatments for Postoperative Nausea & Vomiting (PONV)
Time Frame
from moment of surgery until hospital discharge. on average 8 hours after surgery
Title
opioid use
Description
dosing and frequency of opioid use
Time Frame
at the PACU on average 60 minutes
Title
length of stay at the PACU
Description
Time (in minutes) between the end of surgery and the discharge from the PACU
Time Frame
from moment of surgery until discharge from the PACU. on average 60 minutes after surgery
Title
general patient comfort
Description
VAS for general comfort : from 0 until 100 (0= extremely dissatisfied ; 100= extremely satisfied.
Time Frame
at the moment before of hospital discharge. on average 8 hours after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar, MD,PhD,MSc
Organizational Affiliation
Maria Middelares Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares
City
Gent
State/Province
Oost
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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