Hip FracturesPENG/FNB+ONBNCT06457880
PENG Block vs FNB + ONB in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia
A study testing PENG BLOCK, Femoral Nerve Block and Obturator Nerve Block in people with Hip Fractures and Pain, Postoperative, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Pain, Postoperative, Coagulopathy
- What is being tested?
- PENG BLOCK, Femoral Nerve Block and Obturator Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 1 Jun 2024
- 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 undergo hip surgery
- patients with contraindications at spinal anesthesia
Who cannot join
- allergy at local anesthetic
- age under 18 or weight under 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pericapsular Nerve Group (PENG) Block vs Femoral Nerve Block (FNB) + Obturator Nerve Block (ONB) in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia
The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.
- Being tested
- PENG BLOCK, Femoral Nerve Block, Obturator Nerve Block
- Medical subject headings
- Hip Fractures, Pain, Postoperative, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BLOCKProcedure or surgery
Preoperative ultrasound guided PENG block (ropivacaine 0.5 % 20 mL)
Femoral Nerve BlockProcedure or surgery
Preoperative ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL)
Obturator Nerve BlockProcedure or surgery
Preoperative ultrasound guided obturator nerve block (ropivacaine 0.5 % 5 mL)
| Study group | Role | What they receive |
|---|---|---|
| PENG block | Experimental | Before surgery, Patients undergo to ultrasound guided PENG block administering ropivacaine 0.5 % 20 mL. Receives: Procedure: PENG BLOCK |
| Femoral nerve block + Obturator nerve block | Active comparator | Before surgery, Patients undergo to ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL) + obturator nerve block (ropivacaine 0.5% 5 mL). Receives: Procedure: Femoral Nerve Block; Procedure: Obturator Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative pain
Preoperative pain score expressed by numerical rating scale 0-10
Measured: 30 minutes
Pain following regional anesthesia
Preoperative pain score following regional anesthesia execution expressed by numerical rating scale 0-10
Measured: 30 minutes
Postoperative pain
Postoperative pain score expressed by a numerical rating scale 0-10
Measured: 24 hours
Secondary outcomes (1)
Morphine milligrams (mg) consumption
needed opioid rescue therapy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Gargano, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457880
- Sponsor's protocol ID
- Campus Bio-Medico
- Acronym
- PENG/FNB+ONB
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block vs Femoral Nerve Block (FNB) + Obturator Nerve Block (ONB) in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia
- ClinicalTrials.gov ID
- NCT06457880
- Acronym / sponsor ID
- PENG/FNB+ONB / Campus Bio-Medico
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 13 Jun 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.
The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG block | Experimental | Procedure: PENG BLOCKBefore surgery, Patients undergo to ultrasound guided PENG block administering ropivacaine 0.5 % 20 mL. |
| Femoral nerve block + Obturator nerve block | Active comparator | Procedure: Femoral Nerve Block, Procedure: Obturator Nerve BlockBefore surgery, Patients undergo to ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL) + obturator nerve block (ropivacaine 0.5% 5 mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergo hip surgery
- patients with contraindications at spinal anesthesia
Key exclusion criteria (2 listed)
- allergy at local anesthetic
- age under 18 or weight under 30
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 BLOCKPreoperative ultrasound guided PENG block (ropivacaine 0.5 % 20 mL) | Procedure or surgery | PENG block |
| Femoral Nerve BlockPreoperative ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL) | Procedure or surgery | Femoral nerve block + Obturator nerve block |
| Obturator Nerve BlockPreoperative ultrasound guided obturator nerve block (ropivacaine 0.5 % 5 mL) | Procedure or surgery | Femoral nerve block + Obturator nerve block |
Primary outcome
preoperative pain
Time frame: 30 minutes
Preoperative pain score expressed by numerical rating scale 0-10
Pain following regional anesthesia
Time frame: 30 minutes
Preoperative pain score following regional anesthesia execution expressed by numerical rating scale 0-10
Postoperative pain
Time frame: 24 hours
Postoperative pain score expressed by a numerical rating scale 0-10
1 secondary outcome
Morphine milligrams (mg) consumption
Time frame: 24 hours
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 14 Jun 2024.
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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, Femoral Nerve Block and Obturator Nerve Block in people with Hip Fractures and Pain, Postoperative, run by Campus Bio-Medico University at 1 site in Italy.
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 14 Jun 2024. 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 Italy. 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?
preoperative pain (time frame: 30 minutes). The study lists 3 primary outcomes in all. 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 14 Jun 2024.