Total Knee ArthroplastyPhase 2NCT03692858
IPACK Block in Total Knee Arthroplasty
A Phase 2 study testing Adductor Canal Block plus IPACK Block and Adductor Canal Block in people with Total Knee Arthroplasty, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Adductor Canal Block plus IPACK Block and Adductor Canal Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2018to Jul 2020
- 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 14 to 80 years
- 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
- Previous operation on same knee
- Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
- BMI above 32
- Serious psychiatric, mental and cognitive disorders
- Language barrier
- Block failure
- Chronic opioid, gabapentinoid use
- Severe kidney disfunction
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Asklepieion Hospital of Voula
Athens, 16673
Alexandros Makris, Dr
About this study
Official title: IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study
100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Adductor Canal Block plus IPACK Block, Adductor Canal Block
- Keywords
- arthroplasty, replacement, knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block plus IPACK BlockDrug
Adductor Canal Block plus IPACK Block using Ropivacaine
Adductor Canal BlockDrug
Adductor Canal Block using Ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: Drug: Adductor Canal Block plus IPACK Block |
| Group B | Active comparator | Not described Receives: Drug: Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS scores
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Measured: 48 hours
Morphine consumption
Morphine consumption in mg
Measured: 24 hours
Chronic pain
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting
Measured: 6 months
Secondary outcomes (7)
Delirium occurence
Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium.
Measured: 48 hours
Range of knee motion
Degrees of flexion
Measured: 48 hours
Complications
Measured: 48 hours
Patient mobilization
Patient reporting time of first standing to the side of the bed and number of steps per day
Measured: 5 days
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Measured: 48 hours
Joint function
Maximal flexion / extension
Measured: 6 months
Intestinal function
Time of first passing of rectal gas, reported by the patient
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Oct 2018
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Collaborators
- Aikaterini Kalampokini, Chryssoula Staikou
- Responsible party
- Principal investigator, Alexandros Makris, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692858
- Sponsor's protocol ID
- 8885/20-06-2018
- Status last verified
- Oct 2019
- First submitted
- 30 Sep 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study
- ClinicalTrials.gov ID
- NCT03692858
- Acronym / sponsor ID
- 8885/20-06-2018
- Conditions
- Total Knee Arthroplasty
- Keywords
- arthroplasty, replacement, knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Collaborators
- Aikaterini Kalampokini, Chryssoula Staikou
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 2 Oct 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.
100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Adductor Canal Block plus IPACK Block |
| Group B | Active comparator | Drug: Adductor Canal Block |
Who may qualify
- Ages
- 14 to 80 years
- 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 (8 listed)
- Previous operation on same knee
- Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
- BMI above 32
- Serious psychiatric, mental and cognitive disorders
- Language barrier
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 |
|---|---|---|
| Adductor Canal Block plus IPACK BlockAdductor Canal Block plus IPACK Block using Ropivacaine | Drug | Group A |
| Adductor Canal BlockAdductor Canal Block using Ropivacaine | Drug | Group B |
Primary outcome
NRS scores
Time frame: 48 hours
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Morphine consumption
Time frame: 24 hours
Morphine consumption in mg
Chronic pain
Time frame: 6 months
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting
7 secondary outcomes
Delirium occurence
Time frame: 48 hours
Range of knee motion
Time frame: 48 hours
Complications
Time frame: 48 hours
Patient mobilization
Time frame: 5 days
Patient satisfaction
Time frame: 48 hours
Joint function
Time frame: 6 months
Intestinal function
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adductor Canal Block plus IPACK Block and Adductor Canal Block in people with Total Knee Arthroplasty, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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 8 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: status not confirmed, as of the sponsor's last update on 22 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 Greece. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Makris (+306947076446, makrisalexandros@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS scores (time frame: 48 hours). The study lists 3 primary outcomes in all. 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 22 Oct 2019.