Total Knee ArthroplastyIPACKNCT03704831
Comparison of Analgesic Efficiency Between IPACK Block and Surgical Infiltration After Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical infiltration after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block and Injection of local anesthetics during total knee arthroplasty by surgical infiltration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2018to 30 Nov 2019
- Phase
- Observational
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults patients after a total knee arthroplasty
Who may be able to join
- All adults patients after a total knee arthroplasty since november 2015
Who cannot join
- Child, non primitive surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficiency Between IPACK Block (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) and Surgical Infiltration After Total Knee Arthroplasty
The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical infiltration after total knee arthroplasty. The main objective is to compare cumulative morphine consumption the first 24 hours after surgery. The secondary objectives are to compare pain scores, types and amounts of other analgesics needed during the first 24 hours after surgery.
Read the detailed description
After patient agreement, data will be collected on patient records and will be compared into 2 groups.
Data will be :
- cumulative consumption of morphine during the first 24 hours after surgery
- pain scores during the first 24 hours after surgery
- amount of analgesics during the first 24 hours after surgery
- maximal pain score during the first 24 hours after surgery
- Conditions
- Total Knee Arthroplasty
- Being tested
- Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block, Injection of local anesthetics during total knee arthroplasty by surgical infiltration
- Keywords
- Locoregional anesthesia, IPACK block, surgical infiltration, Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK blockOther
Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee)
Injection of local anesthetics during total knee arthroplasty by surgical infiltrationOther
Injection of local anesthetics during total knee arthroplasty by surgical infiltration.
| Study group | Role | What they receive |
|---|---|---|
| IPACK group | IPACK group Receives: Other: Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block | |
| Surgical infiltration group | Surgical infiltration group Receives: Other: Injection of local anesthetics during total knee arthroplasty by surgical infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic need
Morphine consumption during the first 24 hours after total knee arthroplasty
Measured: 24 hours
Secondary outcomes (4)
Pain scores in the recovery room
Pain scores in the recovery room during the first 24 hours after surgery using the EVA scale
Measured: 24 hours
maximal pain score
maximal pain score during the first 24 hours after surgery using the EVA scale
Measured: 24 hours
Description of the analgesics administered
types of other analgesics needed during the first 24 hours after surgery
Measured: 24 hours
amount other analgesics
amount other analgesics needed during the first 24 hours after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start20 Oct 2018
- Primary completion1 Nov 2019
- Study completion30 Nov 2019
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Capdevila, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704831
- Sponsor's protocol ID
- RECHMPL18_0304
- Acronym
- IPACK
- Status last verified
- Mar 2020
- First submitted
- 24 Sep 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficiency Between IPACK Block (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) and Surgical Infiltration After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03704831
- Acronym / sponsor ID
- IPACK / RECHMPL18_0304
- Conditions
- Total Knee Arthroplasty
- Keywords
- Locoregional anesthesia, IPACK block, surgical infiltration, Total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 15 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.
The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical infiltration after total knee arthroplasty. The main objective is to compare cumulative morphine consumption the first 24 hours after surgery. The secondary objectives are to compare pain scores, types and amounts of other analgesics needed during the first 24 hours after surgery.
Detailed description
After patient agreement, data will be collected on patient records and will be compared into 2 groups.
Data will be :
- cumulative consumption of morphine during the first 24 hours after surgery
- pain scores during the first 24 hours after surgery
- amount of analgesics during the first 24 hours after surgery
- maximal pain score during the first 24 hours after surgery
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPACK group | – | Other: Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK blockIPACK group |
| Surgical infiltration group | – | Other: Injection of local anesthetics during total knee arthroplasty by surgical infiltrationSurgical infiltration group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients after a total knee arthroplasty
Key inclusion criteria (1 listed)
- All adults patients after a total knee arthroplasty since november 2015
Key exclusion criteria (1 listed)
- Child, non primitive surgery
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 |
|---|---|---|
| Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK blockInjection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) | Other | IPACK group |
| Injection of local anesthetics during total knee arthroplasty by surgical infiltrationInjection of local anesthetics during total knee arthroplasty by surgical infiltration. | Other | Surgical infiltration group |
Primary outcome
Analgesic need
Time frame: 24 hours
Morphine consumption during the first 24 hours after total knee arthroplasty
4 secondary outcomes
Pain scores in the recovery room
Time frame: 24 hours
maximal pain score
Time frame: 24 hours
Description of the analgesics administered
Time frame: 24 hours
amount other analgesics
Time frame: 24 hours
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 Mar 2020.
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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.
Xavier Capdevila, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 1 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 Mar 2020. 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 France. 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.
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?
Analgesic need (time frame: 24 hours). 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 Mar 2020.