AnesthesiaAPUCNCT04916158
Evaluation of the Effectiveness of an Accelerated Rehabilitation Protocol Based on Multimodal Analgesia Optimization for Uni-compartmental Knee Prosthesis Surgery
An observational study of Anesthesia, run by University Hospital, Brest at 1 site in France.
Trial summary
Today, prosthetic replacement for osteoarthritis of the knee is a frequent surgery. In France, nearly 100,000 knee arthroplasties are performed each year . Over the last two decades, there has been growing interest in performing single compartment knee replacement (SKR) surgery in patients with isolated single… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2021to 31 Jan 2022
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Patients with programmed SKR
Who may be able to join
- Patients with programmed SKR,
- >18 and < 85 years of age,
- Score ASA 1-2,
- No cognitive impairment,
- No thromboembolic TCDA,
- Without CI to local anesthetics, analgesics,
- Accepting outpatient care
- No opposition formulated
Who cannot join
- <18 years and >85 years
- Patients under legal protection (guardianship, curatorship, ...)
- Refusal to participate
- Support for a total knee prosthesis,
- Emergency surgery or revision surgery,
- ASA3-4,
Show all 9Show fewer
- SAOS not fitted,
- Allergy or hypersensitivity to local anesthetics,
- Outpatient discharge criteria not met.
Trial locations and contacts
1 site in 1 country.
Claire-Marine Grayo, Doctorat contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Claire-Marine Grayo
About this study
Official title: Evaluation of the Effectiveness of an Accelerated Rehabilitation Protocol Based on Multimodal Analgesia Optimization for Uni-compartmental Knee Prosthesis Surgery: Observational, Prospective, Monocentric "Before-after"
Today, prosthetic replacement for osteoarthritis of the knee is a frequent surgery. In France, nearly 100,000 knee arthroplasties are performed each year . Over the last two decades, there has been growing interest in performing single compartment knee replacement (SKR) surgery in patients with isolated single compartment osteoarthritis. The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) . Pain control is one of the major elements of outpatient management of CKD . Prosthetic knee surgery is very painful, the median pain is rated at 5 out of 10 and on average we use 32 milligrams of morphine . The efficiency of the adductor canal block is effective in this context, it avoids the motor block obtained by the femoral block, therefore interesting for ambulatory management in view of a resumption of the fast walking foreseen for the patient. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that pass through this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia It is therefore often performed with an adductor canal block for multimodal analgesia. This block is performed in several facilities, and data are increasingly emerging on its effectiveness .
Thus, based on the recommendations of the French Society of Anesthesia and Resuscitation, on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 the objective of this study is to evaluate the relevance of a protocol concerning prosthetic knee replacement (PUC) in ambulatory care, based on optimized pain control.
Read the detailed description
In France, nearly 100,000 knee arthroplasties are performed each year . Knee prostheses generate a functional benefit demonstrated in the literature and limited perioperative morbidity and mortality. Over the past two decades, there has been growing interest in the use of single-compartment knee arthroplasty (SKR) in patients with isolated single-compartment osteoarthritis (OA). The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) Improvements in perioperative care with regard to analgesia, anesthesia, but also nursing care and rehabilitation have led to a significant reduction in length of stay. Effective pain management is essential and is a necessary condition for early mobilization and a reduction in length of stay. Cross et al. and Berger et al. have shown that reducing the length of stay of patients hospitalized after knee arthroplasty can be achieved not only without compromising patient safety, but also without compromising patient satisfaction .
Anticipating pain control represents a major asset for ambulatory management. As early as the end of the 1990s, it was demonstrated that pain control is the main parameter in ambulatory surgery .prosthetic knee surgery is a very painful surgery. The efficiency of the adductor canal block is effective in this context. It reduces the motor block obtained at the level of the femoral block, which is particularly interesting for ambulatory management with a view to the patient's planned fast walking. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that travel in this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia,so it is often performed with an adductor canal block in a multimodal analgesic pathway. Although this block is performed in several institutions, data is still emerging on its effectiveness. For example, a randomized trial in a single institution involving 86 patients undergoing GPT revealed that the combination of IPACK, adductor canal block and periarticular infiltration improved postoperative analgesia and reduced opioid consumption compared to periarticular injection alone .
Thus, based on the SFAR recommendations on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 , we set up a protocol for a feasibility study of prosthetic knee replacement (PUC) on an outpatient basis, based on optimized pain control.
- Conditions
- Anesthesia
- Keywords
- IPACK, knee arthroplasty, ambulatory
What is being measured
The primary outcome is the main question the study is designed to answer.
Test get up and go test measured from day 0 to day 3. The test is successful if the score is >1
Measured: Day 0 to Day 3
Secondary outcomes (3)
evaluation of the patient's recovery by the QOR-15 questionnaire at 24 and 48 hours,
quality of recovery
Measured: 24 and 48 hours
evaluation of visual analogue pain scale up to Day 5 postoperatively
Measured: day 5
evaluation of morphine consumption up to Day 5 postoperatively
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start7 Jan 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916158
- Sponsor's protocol ID
- 29BRC20.0324
- Acronym
- APUC
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of an Accelerated Rehabilitation Protocol Based on Multimodal Analgesia Optimization for Uni-compartmental Knee Prosthesis Surgery: Observational, Prospective, Monocentric "Before-after"
- ClinicalTrials.gov ID
- NCT04916158
- Acronym / sponsor ID
- APUC / 29BRC20.0324
- Conditions
- Anesthesia
- Keywords
- IPACK, knee arthroplasty, ambulatory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 7 Jun 2021 (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.
Today, prosthetic replacement for osteoarthritis of the knee is a frequent surgery. In France, nearly 100,000 knee arthroplasties are performed each year . Over the last two decades, there has been growing interest in performing single compartment knee replacement (SKR) surgery in patients with isolated single compartment osteoarthritis. The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) . Pain control is one of the major elements of outpatient management of CKD . Prosthetic knee surgery is very painful, the median pain is rated at 5 out of 10 and on average we use 32 milligrams of morphine . The efficiency of the adductor canal block is effective in this context, it avoids the motor block obtained by the femoral block, therefore interesting for ambulatory management in view of a resumption of the fast walking foreseen for the patient. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that pass through this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia It is therefore often performed with an adductor canal block for multimodal analgesia. This block is performed in several facilities, and data are increasingly emerging on its effectiveness .
Thus, based on the recommendations of the French Society of Anesthesia and Resuscitation, on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 the objective of this study is to evaluate the relevance of a protocol concerning prosthetic knee replacement (PUC) in ambulatory care, based on optimized pain control.
Detailed description
In France, nearly 100,000 knee arthroplasties are performed each year . Knee prostheses generate a functional benefit demonstrated in the literature and limited perioperative morbidity and mortality. Over the past two decades, there has been growing interest in the use of single-compartment knee arthroplasty (SKR) in patients with isolated single-compartment osteoarthritis (OA). The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) Improvements in perioperative care with regard to analgesia, anesthesia, but also nursing care and rehabilitation have led to a significant reduction in length of stay. Effective pain management is essential and is a necessary condition for early mobilization and a reduction in length of stay. Cross et al. and Berger et al. have shown that reducing the length of stay of patients hospitalized after knee arthroplasty can be achieved not only without compromising patient safety, but also without compromising patient satisfaction .
Anticipating pain control represents a major asset for ambulatory management. As early as the end of the 1990s, it was demonstrated that pain control is the main parameter in ambulatory surgery .prosthetic knee surgery is a very painful surgery. The efficiency of the adductor canal block is effective in this context. It reduces the motor block obtained at the level of the femoral block, which is particularly interesting for ambulatory management with a view to the patient's planned fast walking. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that travel in this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia,so it is often performed with an adductor canal block in a multimodal analgesic pathway. Although this block is performed in several institutions, data is still emerging on its effectiveness. For example, a randomized trial in a single institution involving 86 patients undergoing GPT revealed that the combination of IPACK, adductor canal block and periarticular infiltration improved postoperative analgesia and reduced opioid consumption compared to periarticular injection alone .
Thus, based on the SFAR recommendations on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 , we set up a protocol for a feasibility study of prosthetic knee replacement (PUC) on an outpatient basis, based on optimized pain control.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with programmed SKR
Key inclusion criteria (8 listed)
- Patients with programmed SKR,
- >18 and < 85 years of age,
- Score ASA 1-2,
- No cognitive impairment,
- No thromboembolic TCDA,
Key exclusion criteria (9 listed)
- <18 years and >85 years
- Patients under legal protection (guardianship, curatorship, ...)
- Refusal to participate
- Support for a total knee prosthesis,
- Emergency surgery or revision surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test get up and go test measured from day 0 to day 3. The test is successful if the score is >1
Time frame: Day 0 to Day 3
3 secondary outcomes
evaluation of the patient's recovery by the QOR-15 questionnaire at 24 and 48 hours,
Time frame: 24 and 48 hours
evaluation of visual analogue pain scale up to Day 5 postoperatively
Time frame: day 5
evaluation of morphine consumption up to Day 5 postoperatively
Time frame: day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Claire-Marine Grayo, Doctorat contact
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 Anesthesia, run by University Hospital, Brest 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 8 inclusion and 9 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 7 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quentin HERBEL (0618136736, quentinherbel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test get up and go test measured from day 0 to day 3. The test is successful if the score is >1 (time frame: Day 0 to Day 3). 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 7 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.