AnalgesiaAPINCT06675916
Assessment of PENG Block Analgesia Versus Intra-articular Infiltration in Hip Prosthesis Surgery
A study testing PENG Block with lidocaine hydrochloride and Intra-articular infiltration with lidocaine hydrochloride in people with Analgesia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. Pain management (analgesia) after hip prosthetic surgery remains a challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- PENG Block with lidocaine hydrochloride and Intra-articular infiltration with lidocaine hydrochloride
- 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
- 1 Mar 2022to 31 Mar 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 hip prosthesis placement via the anterior approach
Who cannot join
- Patient with local anesthesia contraindication.
- Patient with a high level of dependency, defined by level 1 or 2 of Iso Ressources Group (GIR).
Trial locations and contacts
1 site in 1 country.
About this study
After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours.
Pain management (analgesia) after hip prosthetic surgery remains a challenge. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact.
Read more
The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits.
A new peripheral nerve block, the PENG block has shown very encouraging results on postoperative analgesia quality.
In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration during mini-invasive anterior hip prosthesis surgery.
Read the detailed description
Each year, around140 000 patients undergo total hip arthroplasty. After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. However, more and more patients want to no longer suffer after surgery. Indeed, if postoperative pain is moderate at rest, it is often exacerbated by movement. Severe pain occurs in 50 % of patients at rest and in 70% of patients during mobilization.
Pain management (analgesia) after hip prosthetic surgery remains a challenge for the anesthesiologist. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact. Quality analgesia is therefore essential to reduce post-operative pain and improve functional rehabilitation in patients undergoing hip surgery.
The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits: rapid and non-lasting effect of analgesia or poor targeting of all nerves of hip joint.
A new peripheral nerve block, the PENG block, identified during a recent anatomical study in 2018, has shown very encouraging results on postoperative analgesia quality on several small series of patients.
In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration and therefore reduce the intraoperative opioid consumption during mini-invasive anterior hip prosthesis surgery under general anaesthesia.
- Conditions
- Analgesia
- Being tested
- PENG Block with lidocaine hydrochloride, Intra-articular infiltration with lidocaine hydrochloride
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG Block with lidocaine hydrochlorideProcedure or surgery
Intervention is ultrasound-guided PENG block analgesia with lidocaine hydrochloride
Intra-articular infiltration with lidocaine hydrochlorideProcedure or surgery
Intervention is intra-articular analgesia with lidocaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| PENG block | Experimental | Total hip prosthesis with infiltration of lidocaine hydrochloride by ultrasound-guided PENG block Receives: Procedure: PENG Block with lidocaine hydrochloride |
| Intra-articular infiltration | Active comparator | Total hip prosthesis with intra-articular infiltration of lidocaine hydrochloride Receives: Procedure: Intra-articular infiltration with lidocaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine dose
Primary outcome measure is the total morphine quantity administered intraoperatively, in milligrams
Measured: 1 day
Secondary outcomes (4)
Pain level
Pain is assessed with Visual Analogic Scale (0 - 10 points). 0 is the lowest pain value (patient has no pain) whereas 10 is the highest pain value.
Measured: Day 0, 1, 7 and 45
Patient quality of life
Quality of life is assessed with EQ-5D-5L (EUROQOL - 5 dimensions - 5 levels) questionnaire (0 - 100 points). 0 means the worst quality of life whereas 100 means the best quality of life.
Measured: Day 1, 7 and 45
Hip symptoms and limitations
Hip symptoms and limitations assessment relies on HOOS questionnaire (0 - 100 points). 0 is the worst possible score whereas 100 is the best possible score (no symptoms and no limitations)
Measured: Day 45
Hip impact on daily life
Hip impact on daily life is assessed with OXFORD questionnaire (12 - 60 points). 12 is the best patient score (hip has no impact on patient daily life) whereas 60 is the worst patient score
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675916
- Sponsor's protocol ID
- 2021-A00539-32 rgds
- Acronym
- API
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2024
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of PENG Block Analgesia Versus Intra-articular Infiltration in Hip Prosthesis Surgery
- ClinicalTrials.gov ID
- NCT06675916
- Acronym / sponsor ID
- API / 2021-A00539-32 rgds
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 5 Nov 2024 (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.
After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours.
Pain management (analgesia) after hip prosthetic surgery remains a challenge. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact.
The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits.
A new peripheral nerve block, the PENG block has shown very encouraging results on postoperative analgesia quality.
In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration during mini-invasive anterior hip prosthesis surgery.
Detailed description
Each year, around140 000 patients undergo total hip arthroplasty. After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. However, more and more patients want to no longer suffer after surgery. Indeed, if postoperative pain is moderate at rest, it is often exacerbated by movement. Severe pain occurs in 50 % of patients at rest and in 70% of patients during mobilization.
Pain management (analgesia) after hip prosthetic surgery remains a challenge for the anesthesiologist. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact. Quality analgesia is therefore essential to reduce post-operative pain and improve functional rehabilitation in patients undergoing hip surgery.
The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits: rapid and non-lasting effect of analgesia or poor targeting of all nerves of hip joint.
A new peripheral nerve block, the PENG block, identified during a recent anatomical study in 2018, has shown very encouraging results on postoperative analgesia quality on several small series of patients.
In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration and therefore reduce the intraoperative opioid consumption during mini-invasive anterior hip prosthesis surgery under general anaesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG block | Experimental | Procedure: PENG Block with lidocaine hydrochlorideTotal hip prosthesis with infiltration of lidocaine hydrochloride by ultrasound-guided PENG block |
| Intra-articular infiltration | Active comparator | Procedure: Intra-articular infiltration with lidocaine hydrochlorideTotal hip prosthesis with intra-articular infiltration of lidocaine hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient, male or female, over 18 years old.
- Patient scheduled for hip prosthesis placement via the anterior approach
Key exclusion criteria (2 listed)
- Patient with local anesthesia contraindication.
- Patient with a high level of dependency, defined by level 1 or 2 of Iso Ressources Group (GIR).
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 |
|---|---|---|
| PENG Block with lidocaine hydrochlorideIntervention is ultrasound-guided PENG block analgesia with lidocaine hydrochloride | Procedure or surgery | PENG block |
| Intra-articular infiltration with lidocaine hydrochlorideIntervention is intra-articular analgesia with lidocaine hydrochloride | Procedure or surgery | Intra-articular infiltration |
Primary outcome
Morphine dose
Time frame: 1 day
Primary outcome measure is the total morphine quantity administered intraoperatively, in milligrams
4 secondary outcomes
Pain level
Time frame: Day 0, 1, 7 and 45
Patient quality of life
Time frame: Day 1, 7 and 45
Hip symptoms and limitations
Time frame: Day 45
Hip impact on daily life
Time frame: Day 45
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.
- 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?
A study testing PENG Block with lidocaine hydrochloride and Intra-articular infiltration with lidocaine hydrochloride in people with 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 2 inclusion and 2 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?
Morphine dose (time frame: 1 day). 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.