Hip FracturesED-PENGBLOCKNCT05673486
Regional Anesthesia by PENG-Block in Emergency Department
A study testing PENG Block and Multimodal analgesia in people with Hip Fractures, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
The study is a single-centre, open-label randomized comparative trial. Adult patients admitted to the emergency department for a hip fracture will be enrolled. Pericapsular nerve block (PENG-block) is a regional anesthesia technique developed primarily as an analgesic technique in a perioperative setting during hip… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- PENG Block and Multimodal analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2023to 25 Dec 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
- Adult patients (≥18 years old) admitted to the emergency department for a hip fracture
- Pain assessed by VAS/NRS ≥ 3 when the clinical suspicion of hip fracture is confirmed by the emergency physician
- Patients capable of expressing his/her consent prior to participation in the study
- Affiliated to or beneficiary of a social security regimen
Who cannot join
- Patients for who it is impossible to collect the pain assessment scale
- Patients with known or suspected bleeding disorders :
- Personal and family history of bleeding symptoms (spontaneous or induced)
- Clinical signs suggesting a haemostasis disorder
- Patient on anticoagulant at a curative dose with a very high risk of bleeding (labile International Normalized Ratio (INR), mechanical valve, acute kidney failure and treatment with direct oral anticoagulants)
- Inherited bleeding disorder (Hemophilia A, Hemophilia B, Von Willebrand disease, Fibrinogen deficiency, Factor XII deficiency)
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- Pathologies that may interfere with hemostasis: advanced liver disease, decompensated hematological disease, collagen diseases such as Ehlers-Danlos disease
- Patients in whom it is impossible to perform the PENG-Block: Body Mass Index (BMI) > 40, adenopathy or infection at the puncture site, allergy to the anesthetics used
- Pregnant, parturient or breastfeeding women
- Patients under judicial protection or judicial safeguard
- Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Regional Anesthesia by PENG-Block in Patients Diagnosed With Hip Fractures in the Emergency Department: an Open-label Randomized Controlled Trial
The study is a single-centre, open-label randomized comparative trial. Adult patients admitted to the emergency department for a hip fracture will be enrolled.
Pericapsular nerve block (PENG-block) is a regional anesthesia technique developed primarily as an analgesic technique in a perioperative setting during hip fractures related surgical procedures. Some authors propose the use of PENG-Block as an alternative to fascia iliaca block and femoral block for the analgesic management of hip fracture in the emergency department, but scientific evidence is weak in this setting.
The hypothesis of this study is that the use of PENG Block in the emergency department provides a better pain management for patients suffering from hip fractures with less opioid use.
Read the detailed description
Pericapsular nerve block (PENG-block) is a regional anesthesia technique first described in 2018 and developed primarily as an analgesic technique in a perioperative setting during hip fractures related surgical procedures. The analgesic treatment with PENG-Block prevents motor block and thus reduces risk of intra-hospital falls. It also allows patients to get back on their feet more quickly and thus reduces loss of autonomy and risk of dependency. Moreover, it is a technique with a good safety profile that appears to be appropriate, feasible and effective in the context of the analgesic management of hip fractures in the emergency department. Therefore, some authors propose the use of PENG Block as an alternative to fascia iliaca block and femoral block for the analgesic management of this type of fracture.
The main objective of this study is to evaluate the effect of PENG Block combined with conventional multimodal analgesia when compared with conventional multimodal analgesia alone in terms of reduction of total morphine consumption in patients admitted to the emergency department for a hip fracture. The primary endpoint is the total morphine consumption from admission up to 24 hours after randomization or until surgery if the patient is operated on before 24 hours. The secondary objectives are : to assess whether the use of PENG-Block has an influence on the pain felt by the patient compared to conventional analgesia alone; to describe the tolerance of analgesia in the 2 groups; to assess whether the use of PENG-Block has an influence on the duration of hospitalization in the emergency department compared to conventional analgesia alone.
- Conditions
- Hip Fractures
- Being tested
- PENG Block, Multimodal analgesia
- Keywords
- Regional anesthesia, PENG block, Morphine consumption, Opioid sparing, Multimodal analgesia, Femoral neck fracture, intertrochanteric region fracture, Emergency department, Emergency medicine physician
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockCombination product
With the patient in the supine position, the ultrasound probe is placed on a transverse plane over the anterior superior iliac spine (ASIS). Once the ASIS is identified, the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees, parallel to the inguinal crease. The transducer is then slid medially along this axis until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and the psoas tendon is clearly identified, serving as anatomic landmarks.
Sliding the probe distally or gently tilting the caudal will expose the head of the femur. Returning to the initial starting position, a needle is inserted in-plane, from lateral to medial, in the plane between the psoas tendon and the pubic ramus. 100 mg of ropivacaine is then deposited in this plane, lifting the psoas tendon.
Multimodal analgesiaCombination product
Multimodal analgesia is administered to patients as follows : 2-3 mg of morphine (2mg if patient's weight <60kg; 3mg if patient's weight >60kg) + Paracetamol 1g/8h and Nefopam 20mg/8h. Frequency of morphine administration depends on the assessed pain.
| Study group | Role | What they receive |
|---|---|---|
| PENG block + multimodal IV analgesia | Experimental | PENG block + multimodal IV analgesia (Nefopam, Paracetamol, Morphine) Receives: Combination Product: PENG Block; Combination Product: Multimodal analgesia |
| Multimodal analgesia alone | Active comparator | Multimodal IV analgesia (Nefopam, Paracetamol, Morphine) Receives: Combination Product: Multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Total morphine consumption in mg per hour from admission up to 24 hours after randomization or until surgery if the patient is operated on before 24 hours
Measured: Up to 24 hours after randomization
Secondary outcomes (3)
Pain intensity according to a Numeric Rating Scale (NRS)
The patient's pain will be assessed using a Numeric Rating Scale at the start of care in the emergency department, when the clinical suspicion of hip fracture is confirmed by the emergency doctor, then every hour in the emergency room and every 4 hours in the surgery department for 24 hours or until transfer to the operating room if the surgery takes place before.
The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.
Measured: Up to 24 hours after randomization
Presence of side effects
The tolerance of analgesic treatments will be assessed by evaluating the presence or absence of side effects, during the first 24 hours of treatment or until surgery if it takes place before :
Side effects related to opioids such as Confusion, Bradypnea, Nausea or vomiting Side effects related to PENG-Block such as Pain at the puncture site, Acute retention of urine, Bleeding Any other adverse effects occurring during the study will be collected.
Measured: Up to 24 hours after randomization
Duration of hospitalization in the emergency department
Duration of care in hours at the emergency department.
Measured: Up to 24 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start31 Mar 2023
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Laurent CAUMON, MD, Study director, Centre Hospitalier de Hyères
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673486
- Sponsor's protocol ID
- 2022-CHITS-011
- Other IDs
- 2022-A02203-40
- Acronym
- ED-PENGBLOCK
- Status last verified
- Nov 2025
- First submitted
- 2 Jan 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calati P, Lenoir C, Kamel LC, Contie N, Firoloni JD, Sichez A, Sebai A, Chelly J, Caumon L. Effectiveness of pericapsular nerve group block for hip fracture pain management in the emergency department: results of the ED-PENG-B randomised controlled trial. BMC Emerg Med. 2025 Nov 26;25(1):245. doi: 10.1186/s12873-025-01401-x.
PubMed 41299315
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Regional Anesthesia by PENG-Block in Patients Diagnosed With Hip Fractures in the Emergency Department: an Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05673486
- Acronym / sponsor ID
- ED-PENGBLOCK / 2022-CHITS-011
- Conditions
- Hip Fractures
- Keywords
- Regional anesthesia, PENG block, Morphine consumption, Opioid sparing, Multimodal analgesia, Femoral neck fracture, intertrochanteric region fracture, Emergency department, Emergency medicine physician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 6 Jan 2023 (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 study is a single-centre, open-label randomized comparative trial. Adult patients admitted to the emergency department for a hip fracture will be enrolled.
Pericapsular nerve block (PENG-block) is a regional anesthesia technique developed primarily as an analgesic technique in a perioperative setting during hip fractures related surgical procedures. Some authors propose the use of PENG-Block as an alternative to fascia iliaca block and femoral block for the analgesic management of hip fracture in the emergency department, but scientific evidence is weak in this setting.
The hypothesis of this study is that the use of PENG Block in the emergency department provides a better pain management for patients suffering from hip fractures with less opioid use.
Detailed description
Pericapsular nerve block (PENG-block) is a regional anesthesia technique first described in 2018 and developed primarily as an analgesic technique in a perioperative setting during hip fractures related surgical procedures. The analgesic treatment with PENG-Block prevents motor block and thus reduces risk of intra-hospital falls. It also allows patients to get back on their feet more quickly and thus reduces loss of autonomy and risk of dependency. Moreover, it is a technique with a good safety profile that appears to be appropriate, feasible and effective in the context of the analgesic management of hip fractures in the emergency department. Therefore, some authors propose the use of PENG Block as an alternative to fascia iliaca block and femoral block for the analgesic management of this type of fracture.
The main objective of this study is to evaluate the effect of PENG Block combined with conventional multimodal analgesia when compared with conventional multimodal analgesia alone in terms of reduction of total morphine consumption in patients admitted to the emergency department for a hip fracture. The primary endpoint is the total morphine consumption from admission up to 24 hours after randomization or until surgery if the patient is operated on before 24 hours. The secondary objectives are : to assess whether the use of PENG-Block has an influence on the pain felt by the patient compared to conventional analgesia alone; to describe the tolerance of analgesia in the 2 groups; to assess whether the use of PENG-Block has an influence on the duration of hospitalization in the emergency department compared to conventional analgesia alone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG block + multimodal IV analgesia | Experimental | Combination Product: PENG Block, Combination Product: Multimodal analgesiaPENG block + multimodal IV analgesia (Nefopam, Paracetamol, Morphine) |
| Multimodal analgesia alone | Active comparator | Combination Product: Multimodal analgesiaMultimodal IV analgesia (Nefopam, Paracetamol, Morphine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years old) admitted to the emergency department for a hip fracture
- Pain assessed by VAS/NRS ≥ 3 when the clinical suspicion of hip fracture is confirmed by the emergency physician
- Patients capable of expressing his/her consent prior to participation in the study
- Affiliated to or beneficiary of a social security regimen
Key exclusion criteria (11 listed)
- Patients for who it is impossible to collect the pain assessment scale
- Patients with known or suspected bleeding disorders :
- Patients in whom it is impossible to perform the PENG-Block: Body Mass Index (BMI) > 40, adenopathy or infection at the puncture site, allergy to the anesthetics used
- Pregnant, parturient or breastfeeding women
- Patients under judicial protection or judicial safeguard
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 BlockWith the patient in the supine position, the ultrasound probe is placed on a transverse plane over the anterior superior iliac spine (ASIS). Once the ASIS is identified, the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees, parallel to the inguinal crease. The transducer is then slid medially along this axis until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and the psoas tendon is clearly identified, serving as anatomic landmarks. Sliding the probe distally or gently tilting the caudal will expose the head of the femur. Returning to the initial starting position, a needle is inserted in-plane, from lateral to medial, in the plane between the psoas tendon and the pubic ramus. 100 mg of ropivacaine is then deposited in this plane, lifting the psoas tendon. | Combination product | PENG block + multimodal IV analgesia |
| Multimodal analgesiaMultimodal analgesia is administered to patients as follows : 2-3 mg of morphine (2mg if patient's weight <60kg; 3mg if patient's weight >60kg) + Paracetamol 1g/8h and Nefopam 20mg/8h. Frequency of morphine administration depends on the assessed pain. | Combination product | Multimodal analgesia alone, PENG block + multimodal IV analgesia |
Primary outcome
Total morphine consumption
Time frame: Up to 24 hours after randomization
Total morphine consumption in mg per hour from admission up to 24 hours after randomization or until surgery if the patient is operated on before 24 hours
3 secondary outcomes
Pain intensity according to a Numeric Rating Scale (NRS)
Time frame: Up to 24 hours after randomization
Presence of side effects
Time frame: Up to 24 hours after randomization
Duration of hospitalization in the emergency department
Time frame: Up to 24 hours after randomization
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 5 Dec 2025.
- Results publication: PubMed 41299315Calati P, Lenoir C, Kamel LC, Contie N, Firoloni JD, Sichez A, Sebai A, Chelly J, Caumon L. Effectiveness of pericapsular nerve group block for hip fracture pain management in the emergency department: results of the ED-PENG-B randomised controlled trial. BMC Emerg Med. 2025 Nov 26;25(1):245. doi: 10.1186/s12873-025-01401-x.
- 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.
Laurent CAUMON, MD study director
Centre Hospitalier de Hyères
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 and Multimodal analgesia in people with Hip Fractures, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer 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 11 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 5 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?
Total morphine consumption (time frame: Up to 24 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673486, which also lists 1 linked publication.
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 5 Dec 2025.