Hip ArthropathyPENGORINFNCT06257160
Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery
A study testing Surgical infiltration and PENG Block ultrasound-guided in people with Hip Arthropathy and Hip Arthrosis, run by CHU de Reims at 1 site in France.
Trial summary
Pain after total hip replacement (THR) surgery is severe. The target population is elderly and comorbid. Level III analgesics are responsible for significant side effects in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy, Hip Arthrosis
- What is being tested?
- Surgical infiltration and PENG Block ultrasound-guided
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2024to 18 Sep 2025
- 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
- Patients eligible for posterior total hip replacement surgery at Reims University Hospital
- Patients agreeing to take part in the research and having signed the informed consent form
- Patients of full age
- Patients affiliated to a social security scheme
Who cannot join
- Minor patients
- Patients protected by law
- Pregnant and breast-feeding women
- Patients with allergy to local anesthetics
- Patients with neuropathy
- Patients with an ASA score greater than or equal to 4
Show all 14Show fewer
- Patients undergoing revision surgery on a total hip prosthesis
- Patients undergoing anterior total hip replacement surgery
- Patients suffering from a femur fracture
- Patients with a contraindication to Peng block.
- Patients refusing one of the proposed techniques.
- Persons deprived of their liberty by judicial or administrative decision.
- Persons under psychiatric care
- Persons unable to express their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Pain after total hip replacement (THR) surgery is severe. The target population is elderly and comorbid. Level III analgesics are responsible for significant side effects in this population. Locoregional analgesia, by reducing the consumption of painkillers, is an effective way of reducing morphine or morphine agonist consumption in this surgery. Furthermore, these techniques fit in perfectly with the objectives of accelerated rehabilitation after surgery. Surgical infiltration is a frequently used and effective analgesic technique. PENG block is a new locoregional anesthesia technique which initial results show promising analgesic efficacy and the absence of loss of strength through motor block.
In February 2022, we carried out a survey of national anesthetic practices in posterior hip arthroplasty, with the help of the SFAR (Société Française d'Anesthésie-Réanimation).
Read more
It shows that, despite the lack of plentiful literature on the subject, the PENG block is currently the most frequently performed pre-operative block in hip arthroplasty (PENG block in 39.5% of cases, femoral block in 13% of cases).
The survey also shows that in 41.5% of cases, no block is performed, and only intraoperative surgical infiltration is carried out.
PENG block and surgical infiltration are therefore the two analgesic techniques most frequently used in France today.
It is for these reasons that we feel it is essential to carry out a study comparing these two techniques.
Read the detailed description
The aim of this study was to compare the clinical efficacy of these two locoregional analgesia strategies in posterior total hip replacement surgery: ultrasound-guided PENG block and surgical infiltration.
The study is a superiority randomized, double-blind (patient and evaluator will be blinded to the randomization group), single-center trial.
Two groups of patients will be compared: a group of patients benefiting from the echo-guided PENG block strategy, and a group of patients benefiting from intraoperative surgical infiltration.
The type of treatment (PENG block or surgical infiltration) will be randomized. The target population concerns patients scheduled for posterior total hip replacement surgery at Reims University Hospital If the hypothesis of the superior efficacy of echo-guided block PENG is confirmed, our analgesia strategy for total hip replacement surgery will be modified, enabling us to offer the most effective locoregional analgesia technique and thus reduce the morbidity and mortality associated with morphine consumption.
This could have both a medical and an economic impact, by optimizing post-operative monitoring and convalescence for these patients.
- Conditions
- Hip Arthropathy, Hip Arthrosis
- Being tested
- Surgical infiltration, PENG Block ultrasound-guided
- Keywords
- Analgesia, Hip, Arthroplasty, PENG, locoregional anesthesia, infiltration
- Medical subject headings
- Osteoarthritis, Hip, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical infiltrationProcedure or surgery
During surgery, local anesthetics are injected as follow: in the deep plane and in the subcutaneous territory.
Infiltration of the deep plane corresponds to pericotyloid injection, with particular attention to the posterior subcapsular area, the obturator foramen and the psoas muscle. Infiltration of the muscular planes is added, with infiltration of the gluteal and pelvitrochanteric muscles.
PENG Block ultrasound-guidedProcedure or surgery
We perform the femoral block under ultrasound after anesthesia (general or rachianesthesia). The PENG block is a peripheral diffusion nerve block that specifically targets the articular divisions of the femoral, obturator and accessory obturator nerves.
The femoral nerve innervates the four parts of the joint capsule, with inconsistency in the anterior inferomedial part of the capsule.
The obturator nerve innervates the inferior part of the anterior face of the capsule.
The accessory obturator nerve innervates the medial half of the hip joint capsule in over 50% of cases.
| Study group | Role | What they receive |
|---|---|---|
| Surgical infiltration | Active comparator | Not described Receives: Procedure: Surgical infiltration |
| PENG Block ultrasound-guided | Experimental | Not described Receives: Procedure: PENG Block ultrasound-guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured: At 24 hours postoperative
Secondary outcomes (14)
Pain evaluation
Numeric pain intensity scale
Measured: At 1 hour postoperative
Pain evaluation
Numeric pain intensity scale
Measured: At 2 hours postoperative
Pain evaluation
Numeric pain intensity scale
Measured: At 6 hours postoperative
Pain evaluation
Numeric pain intensity scale
Measured: At 12 hours postoperative
Pain evaluation
Numeric pain intensity scale
Measured: At 24 hours postoperative
Pain evaluation
Numeric pain intensity scale
Measured: At 36 hours postoperative
Pain evaluation
Numeric pain intensity scale
Measured: At 48 hours postoperative
Success or failure at first stand up test
Measured: At 4 hours postoperative
Need for analgesia rescue technique
Measured: At 24 hours postoperative
10 meters walk test
Measured: At 24 hours postoperative
Muscle strength test
Measured: At 24 hours postoperative
Length of hospital stay
Measured: At the end of the stay
Adverse events due to consumption of morphine
Measured: At 24 hours postoperative
Adverse events due to PENG block ou surgical infiltration
Measured: At 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start22 May 2024
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257160
- Sponsor's protocol ID
- PO24003
- Acronym
- PENGORINF
- Status last verified
- Nov 2025
- First submitted
- 6 Feb 2024
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT06257160
- Acronym / sponsor ID
- PENGORINF / PO24003
- Conditions
- Hip Arthropathy, Hip Arthrosis
- Keywords
- Analgesia, Hip, Arthroplasty, PENG, locoregional anesthesia, infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 13 Feb 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.
Pain after total hip replacement (THR) surgery is severe. The target population is elderly and comorbid. Level III analgesics are responsible for significant side effects in this population. Locoregional analgesia, by reducing the consumption of painkillers, is an effective way of reducing morphine or morphine agonist consumption in this surgery. Furthermore, these techniques fit in perfectly with the objectives of accelerated rehabilitation after surgery. Surgical infiltration is a frequently used and effective analgesic technique. PENG block is a new locoregional anesthesia technique which initial results show promising analgesic efficacy and the absence of loss of strength through motor block.
In February 2022, we carried out a survey of national anesthetic practices in posterior hip arthroplasty, with the help of the SFAR (Société Française d'Anesthésie-Réanimation).
It shows that, despite the lack of plentiful literature on the subject, the PENG block is currently the most frequently performed pre-operative block in hip arthroplasty (PENG block in 39.5% of cases, femoral block in 13% of cases).
The survey also shows that in 41.5% of cases, no block is performed, and only intraoperative surgical infiltration is carried out.
PENG block and surgical infiltration are therefore the two analgesic techniques most frequently used in France today.
It is for these reasons that we feel it is essential to carry out a study comparing these two techniques.
Detailed description
The aim of this study was to compare the clinical efficacy of these two locoregional analgesia strategies in posterior total hip replacement surgery: ultrasound-guided PENG block and surgical infiltration.
The study is a superiority randomized, double-blind (patient and evaluator will be blinded to the randomization group), single-center trial.
Two groups of patients will be compared: a group of patients benefiting from the echo-guided PENG block strategy, and a group of patients benefiting from intraoperative surgical infiltration.
The type of treatment (PENG block or surgical infiltration) will be randomized. The target population concerns patients scheduled for posterior total hip replacement surgery at Reims University Hospital If the hypothesis of the superior efficacy of echo-guided block PENG is confirmed, our analgesia strategy for total hip replacement surgery will be modified, enabling us to offer the most effective locoregional analgesia technique and thus reduce the morbidity and mortality associated with morphine consumption.
This could have both a medical and an economic impact, by optimizing post-operative monitoring and convalescence for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical infiltration | Active comparator | Procedure: Surgical infiltration |
| PENG Block ultrasound-guided | Experimental | Procedure: PENG Block ultrasound-guided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients eligible for posterior total hip replacement surgery at Reims University Hospital
- Patients agreeing to take part in the research and having signed the informed consent form
- Patients of full age
- Patients affiliated to a social security scheme
Key exclusion criteria (14 listed)
- Minor patients
- Patients protected by law
- Pregnant and breast-feeding women
- Patients with allergy to local anesthetics
- Patients with neuropathy
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 |
|---|---|---|
| Surgical infiltrationDuring surgery, local anesthetics are injected as follow: in the deep plane and in the subcutaneous territory. Infiltration of the deep plane corresponds to pericotyloid injection, with particular attention to the posterior subcapsular area, the obturator foramen and the psoas muscle. Infiltration of the muscular planes is added, with infiltration of the gluteal and pelvitrochanteric muscles. | Procedure or surgery | Surgical infiltration |
| PENG Block ultrasound-guidedWe perform the femoral block under ultrasound after anesthesia (general or rachianesthesia). The PENG block is a peripheral diffusion nerve block that specifically targets the articular divisions of the femoral, obturator and accessory obturator nerves. The femoral nerve innervates the four parts of the joint capsule, with inconsistency in the anterior inferomedial part of the capsule. The obturator nerve innervates the inferior part of the anterior face of the capsule. The accessory obturator nerve innervates the medial half of the hip joint capsule in over 50% of cases. | Procedure or surgery | PENG Block ultrasound-guided |
Primary outcome
Morphine consumption
Time frame: At 24 hours postoperative
14 secondary outcomes
Pain evaluation
Time frame: At 1 hour postoperative
Pain evaluation
Time frame: At 2 hours postoperative
Pain evaluation
Time frame: At 6 hours postoperative
Pain evaluation
Time frame: At 12 hours postoperative
Pain evaluation
Time frame: At 24 hours postoperative
Pain evaluation
Time frame: At 36 hours postoperative
Pain evaluation
Time frame: At 48 hours postoperative
Success or failure at first stand up test
Time frame: At 4 hours postoperative
Need for analgesia rescue technique
Time frame: At 24 hours postoperative
10 meters walk test
Time frame: At 24 hours postoperative
Muscle strength test
Time frame: At 24 hours postoperative
Length of hospital stay
Time frame: At the end of the stay
Adverse events due to consumption of morphine
Time frame: At 24 hours postoperative
Adverse events due to PENG block ou surgical infiltration
Time frame: At 24 hours postoperative
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 3 Dec 2025.
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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 Surgical infiltration and PENG Block ultrasound-guided in people with Hip Arthropathy and Hip Arthrosis, run by CHU de Reims 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 14 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 3 Dec 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?
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 consumption (time frame: At 24 hours postoperative). 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 3 Dec 2025.