SurgeryPhase 4NCT03599427
Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee Arthroscopy
A Phase 4 study testing systemic lidocaine in people with Surgery and Pain, Postoperative, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Pain, Postoperative, Nausea, Postoperative
- What is being tested?
- systemic lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- patients which are planned for elective knee arthroscopy
- ASA 1 and 2
- knee arthroscopy suitable for intra-articular injection of anesthetics
Who cannot join
- contra-indication for lidocaine, paracetamol or diclofenac
- known history of severe post-operative nausea or vomiting
- knee arthroscopy associated with anterior cruciate ligament reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Added Value of Systemic Lidocaine in Combination With Local Infiltration Analgesia for Knee Arthroscopic Procedures
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.
Read the 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
- Being tested
- systemic lidocaine, Placebo
- Keywords
- postoperative analgesia, knee surgery, intravenous lidocaine
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic lidocaineDrug
Also called linisol 2%
Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).
PlaceboDrug
Also called saline 0.9%
Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)
| Study group | Role | What they receive |
|---|---|---|
| systemic lidocaine | Active comparator | Lidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from moment of surgery until hospital discharge. on average 8 hours after surgery
Secondary outcomes (5)
incidence of Nausea and vomiting
Incidence of postoperative nausea and vomiting
Measured: from moment of surgery until hospital discharge. on average 8 hours after surgery
PONV treatment
Number of pharmacological treatments for Postoperative Nausea \& Vomiting (PONV)
Measured: from moment of surgery until hospital discharge. on average 8 hours after surgery
opioid use
dosing and frequency of opioid use
Measured: at the PACU on average 60 minutes
length of stay at the PACU
Time (in minutes) between the end of surgery and the discharge from the PACU
Measured: from moment of surgery until discharge from the PACU. on average 60 minutes after surgery
general patient comfort
VAS for general comfort : from 0 until 100 (0= extremely dissatisfied ; 100= extremely satisfied.
Measured: at the moment before of hospital discharge. on average 8 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2018
- Primary completion1 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A receives linisol 2%, group B receives placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Alain F Kalmar, MD,PhD,MSc, Principal investigator, Maria Middelares Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599427
- Sponsor's protocol ID
- MMS.2017.032
- Status last verified
- Oct 2019
- First submitted
- 21 Jun 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Systemic Lidocaine in Combination With Local Infiltration Analgesia for Knee Arthroscopic Procedures
- ClinicalTrials.gov ID
- NCT03599427
- Acronym / sponsor ID
- MMS.2017.032
- Conditions
- Surgery, Pain, Postoperative, Nausea, Postoperative, Opioid Use
- Keywords
- postoperative analgesia, knee surgery, intravenous lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A receives linisol 2%, group B receives placebo.
| Arm | Type | Receives |
|---|---|---|
| systemic lidocaine | Active comparator | Drug: systemic lidocaineLidocaine 2% IV bolus: 1.5 mg/kg at induction of anesthesia and at the end of surgery. |
| Placebo | Placebo comparator | Drug: PlaceboSaline 0.9% IV bolus: 0.075 ml/kg at induction of anesthesia and at the end of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- signed informed consent
- patients which are planned for elective knee arthroscopy
- ASA 1 and 2
- knee arthroscopy suitable for intra-articular injection of anesthetics
Key exclusion criteria (3 listed)
- contra-indication for lidocaine, paracetamol or diclofenac
- known history of severe post-operative nausea or vomiting
- knee arthroscopy associated with anterior cruciate ligament reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systemic lidocaineAlso: linisol 2%Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg). | Drug | systemic lidocaine |
| PlaceboAlso: saline 0.9%Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg) | Drug | Placebo |
Primary outcome
Visual Analog Score for pain
Time frame: 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
5 secondary outcomes
incidence of Nausea and vomiting
Time frame: from moment of surgery until hospital discharge. on average 8 hours after surgery
PONV treatment
Time frame: from moment of surgery until hospital discharge. on average 8 hours after surgery
opioid use
Time frame: at the PACU on average 60 minutes
length of stay at the PACU
Time frame: from moment of surgery until discharge from the PACU. on average 60 minutes after surgery
general patient comfort
Time frame: at the moment before of hospital discharge. on average 8 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain F Kalmar, MD,PhD,MSc principal investigator
Maria Middelares Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing systemic lidocaine in people with Surgery and Pain, Postoperative, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score for pain (time frame: from moment of surgery until hospital discharge. on average 8 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.