Hip ProsthesisAPINCT05250492
Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)
A study testing Prosthetic hip surgery in people with Hip Prosthesis and Analgesia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Prosthesis, Analgesia, PENG Block
- What is being tested?
- Prosthetic hip surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2022to 15 May 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, over 18 years old.
- Patient scheduled for anterior hip prosthesis.
- Affiliated patient or beneficiary of a social security scheme.
- Patient having been informed and having signed a free and informed consent.
Who cannot join
- Patient with a contraindication to local anesthesia.
- Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group (GIR).
- Patient participating in another clinical study.
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
- Pregnant, breastfeeding or parturient woman.
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery
The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.
- Conditions
- Hip Prosthesis, Analgesia, PENG Block
- Being tested
- Prosthetic hip surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic hip surgeryProcedure or surgery
Total hip prosthesis performed by an anterior approach with intra-articular infiltration of an anesthetic product intraoperatively.
OR
- Total hip prosthesis performed by an anterior approach with infiltration of the same anesthetic product by ultrasound-guided PENG block intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PENG block | Experimental | Not described Receives: Procedure: Prosthetic hip surgery |
| Patients with intra-articular infiltration | Active comparator | Not described Receives: Procedure: Prosthetic hip surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption in the postoperative care unit
Postoperative morphine consumption (in mg) in the postoperative care unit
Measured: 1 hour
Secondary outcomes (1)
Postoperative morphine équivalent consumption at postoperative day 1
postoperative morphine équivalent consumption (in mg) at postoperative day 1
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start2 Mar 2022
- Primary completion9 Sep 2022
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ProsthesisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250492
- Sponsor's protocol ID
- 2021-A00539-32
- Acronym
- API
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery
- ClinicalTrials.gov ID
- NCT05250492
- Acronym / sponsor ID
- API / 2021-A00539-32
- Conditions
- Hip Prosthesis, Analgesia, PENG Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 22 Feb 2022 (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 main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PENG block | Experimental | Procedure: Prosthetic hip surgery |
| Patients with intra-articular infiltration | Active comparator | Procedure: Prosthetic hip surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, male or female, over 18 years old.
- Patient scheduled for anterior hip prosthesis.
- Affiliated patient or beneficiary of a social security scheme.
- Patient having been informed and having signed a free and informed consent.
Key exclusion criteria (6 listed)
- Patient with a contraindication to local anesthesia.
- Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group (GIR).
- Patient participating in another clinical study.
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
- Pregnant, breastfeeding or parturient woman.
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 |
|---|---|---|
| Prosthetic hip surgeryTotal hip prosthesis performed by an anterior approach with intra-articular infiltration of an anesthetic product intraoperatively. OR - Total hip prosthesis performed by an anterior approach with infiltration of the same anesthetic product by ultrasound-guided PENG block intraoperatively. | Procedure or surgery | Patients with PENG block, Patients with intra-articular infiltration |
Primary outcome
Postoperative morphine consumption in the postoperative care unit
Time frame: 1 hour
Postoperative morphine consumption (in mg) in the postoperative care unit
1 secondary outcome
Postoperative morphine équivalent consumption at postoperative day 1
Time frame: 1 day
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 16 Jul 2026.
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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?
A study testing Prosthetic hip surgery in people with Hip Prosthesis and Analgesia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 6 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 16 Jul 2026. 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?
Postoperative morphine consumption in the postoperative care unit (time frame: 1 hour). 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 16 Jul 2026.