Total Knee ArthroplastyPhase 2NCT03206554
Local Infiltration Analgesia in Total Knee Arthroplasty
A Phase 2 study testing Ropivacaine and Saline in people with Total Knee Arthroplasty and Analgesia, run by Asklepieion Voulas General Hospital.
Trial summary
40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty, Analgesia
- What is being tested?
- Ropivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 2016
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
Who cannot join
- Contraindication for central and/or peripheral nervous blockade
- Reoperation on previous total knee arthroplasty
- History of allergic or other adverse reactions on the agents used in the study
- Chronic opioid or gabapentinoid use
- Serious psychiatric, mental and cognitive disorders
- Language barrier
- Difficulty in understanding or using a patient controlled analgesia device
About this study
Official title: Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.
40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.
- Conditions
- Total Knee Arthroplasty, Analgesia
- Being tested
- Ropivacaine, Saline
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Large volume local anaesthetic intraarticularly
SalineOther
sham injection
| Study group | Role | What they receive |
|---|---|---|
| LIA | Active comparator | Local infiltration analgesia Receives: Drug: Ropivacaine |
| sham LIA | Sham comparator | Saline injections Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured: 24 hours
Secondary outcomes (4)
NRS scores
Measured: 24 hours
Complications
Measured: 24 hours
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No
Measured: 24 hours
Duration of hospitalization
Number of days patients remain in the hospital postoperatively
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexandros Makris, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206554
- Sponsor's protocol ID
- 511/25/09/2015
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tziona D, Papaioannou M, Mela A, Potamianou S, Makris A. Local infiltration analgesia combined with a standardized multimodal approach including an adductor canal block in total knee arthroplasty: a prospective randomized, placebo-controlled, double-blinded clinical trial. J Anesth. 2018 Jun;32(3):326-332. doi: 10.1007/s00540-018-2476-x. Epub 2018 Mar 5.
PubMed 29508066
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.
- ClinicalTrials.gov ID
- NCT03206554
- Acronym / sponsor ID
- 511/25/09/2015
- Conditions
- Total Knee Arthroplasty, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Jul 2017 (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.
40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIA | Active comparator | Drug: RopivacaineLocal infiltration analgesia |
| sham LIA | Sham comparator | Other: SalineSaline injections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
Key exclusion criteria (7 listed)
- Contraindication for central and/or peripheral nervous blockade
- Reoperation on previous total knee arthroplasty
- History of allergic or other adverse reactions on the agents used in the study
- Chronic opioid or gabapentinoid use
- Serious psychiatric, mental and cognitive disorders
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 |
|---|---|---|
| RopivacaineLarge volume local anaesthetic intraarticularly | Drug | LIA |
| Salinesham injection | Other | sham LIA |
Primary outcome
Morphine consumption
Time frame: 24 hours
4 secondary outcomes
NRS scores
Time frame: 24 hours
Complications
Time frame: 24 hours
Patient satisfaction
Time frame: 24 hours
Duration of hospitalization
Time frame: 1 month
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 2 Jul 2017.
- Derived from this study: PubMed 29508066Tziona D, Papaioannou M, Mela A, Potamianou S, Makris A. Local infiltration analgesia combined with a standardized multimodal approach including an adductor canal block in total knee arthroplasty: a prospective randomized, placebo-controlled, double-blinded clinical trial. J Anesth. 2018 Jun;32(3):326-332. doi: 10.1007/s00540-018-2476-x. Epub 2018 Mar 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine and Saline in people with Total Knee Arthroplasty and Analgesia, run by Asklepieion Voulas General Hospital.
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 2 inclusion and 7 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03206554, which also lists 1 linked publication.
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 2 Jul 2017.