Arthropathy of HipPAMTANCT06832995
Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties
An observational study of Arthropathy of Hip and Arthropathy of Knee, run by Hôpital Privé Sévigné at 1 site in France.
Trial summary
Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Hip, Arthropathy of Knee
- What is being tested?
- IV morphine administered during the PACU stay
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Each patient who underwent unilateral knee, total knee and total hip arthroplasty at the Sévigné Private Hospital between January 1, 2023, and December 31, 2023.
Who may be able to join
- Total hip arthroplasty
- Total Knee Arthroplasty
- Uni-compartmental knee arthroplasty (UKA)
Who cannot join
- Bilateral surgery Surgical revision Hip fracture surgery Other osteoarticular procedure(s) associated to hip/knee arthroplasty Refusal to use data Contra-indication of paracetamol, ketoprofen and dexamethasone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties: a Single-center Retrospective Study
Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Sedation occurrence during titration and a VAS score higher than 60/100mm are two independent risk factors for postoperative pain during hospitalization.
The association of NB and multimodal analgesia constitutes the reference in evidence-based recommendations. An adductor or femoral triangle block, alone or associated with periarticular infiltration, is recommended during TKA. During THA, NB associated with surgical periarticular infiltration improves analgesia and rehabilitation This study aims to identify the incidence and risk factors of morphine titration in PACU after lower limb arthroplasty performed by 5 experienced surgeons and using a multimodal analgesic procedure
- Conditions
- Arthropathy of Hip, Arthropathy of Knee
- Being tested
- IV morphine administered during the PACU stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV morphine administered during the PACU stayDrug
IV morphine administered during the PACU stay
| Study group | Role | What they receive |
|---|---|---|
| group T: IV morphine administered during the PACU stay | Not described Receives: Drug: IV morphine administered during the PACU stay | |
| group NT: no titration required in PACU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine titration
Measured: after surgery, in the post-anesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HipStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé Sévigné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832995
- Sponsor's protocol ID
- 2024-HPS
- Acronym
- PAMTA
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties: a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06832995
- Acronym / sponsor ID
- PAMTA / 2024-HPS
- Conditions
- Arthropathy of Hip, Arthropathy of Knee
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hôpital Privé SévignéUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Sedation occurrence during titration and a VAS score higher than 60/100mm are two independent risk factors for postoperative pain during hospitalization.
The association of NB and multimodal analgesia constitutes the reference in evidence-based recommendations. An adductor or femoral triangle block, alone or associated with periarticular infiltration, is recommended during TKA. During THA, NB associated with surgical periarticular infiltration improves analgesia and rehabilitation This study aims to identify the incidence and risk factors of morphine titration in PACU after lower limb arthroplasty performed by 5 experienced surgeons and using a multimodal analgesic procedure
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group T: IV morphine administered during the PACU stay | – | Drug: IV morphine administered during the PACU stay |
| group NT: no titration required in PACU | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each patient who underwent unilateral knee, total knee and total hip arthroplasty at the Sévigné Private Hospital between January 1, 2023, and December 31, 2023.
Key inclusion criteria (3 listed)
- Total hip arthroplasty
- Total Knee Arthroplasty
- Uni-compartmental knee arthroplasty (UKA)
Key exclusion criteria (1 listed)
- Bilateral surgery Surgical revision Hip fracture surgery Other osteoarticular procedure(s) associated to hip/knee arthroplasty Refusal to use data Contra-indication of paracetamol, ketoprofen and dexamethasone
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 |
|---|---|---|
| IV morphine administered during the PACU stayIV morphine administered during the PACU stay | Drug | group T: IV morphine administered during the PACU stay |
Primary outcome
morphine titration
Time frame: after surgery, in the post-anesthetic care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- 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.
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 Arthropathy of Hip and Arthropathy of Knee, run by Hôpital Privé Sévigné 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 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 titration (time frame: after surgery, in the post-anesthetic care unit). 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 18 Feb 2025.