Femoral FractureNCT05840458
Pericapsular Nerve Block in Proximal Femoral Fractures
An observational study of Femoral Fracture, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
Proximal femoral fractures commonly occur above 50 years and regional anesthesia could be a complement in the perioperative treatment of the patients. The use of pericapsular nerve group block (PENG Block) has been proposed to reduce pain. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- PENG Block
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Observational
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unilateral proximal femoral fractures admitted to the emergency room.
Who may be able to join
- patients with unilateral proximal femoral fractures admitted to the emergency room of the Hospital Sírio-Libanes,
- aged 18-105 years
- with the American Society of Anesthesiology (ASA) physical status I, II, or III.
Who cannot join
- allergy to metamizole and/or ropivacaine
- history of mental disorders
- presence of chronic pain as assessed using the Douleur Neuropathique 4 (DN4) questionnaire
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Sírio-Libanês
São Paulo, São Paulo
Pedro P Kimachi, MD, +5511991752029, ppkimachi@yahoo.com.br
About this study
Official title: Effect of Systemic Analgesia and Systemic Analgesia Associated With Pericapsular Nerve Block in Proximal Femoral Fractures
Proximal femoral fractures commonly occur above 50 years and regional anesthesia could be a complement in the perioperative treatment of the patients. The use of pericapsular nerve group block (PENG Block) has been proposed to reduce pain. However, no studies have explored the efficient of the systemic analgesia associated with PENG Block in functional limitation in the preoperative period. In this sense, the main goal of this study is to evaluate the effectiveness of systemic analgesia associated with PENG Block in patients with proximal femoral fractures in the period preceding the surgical procedure.
Read the detailed description
Focus on functional capacity will be measured by the Activity Measure for Post-Acute Care (AM-PAC) short version of the "6 Clicks", pain intensity will be assessed using the numerical rating scale, and opioid consumption. This study will include 21 patients admitted to the Emergency Room with proximal femoral fractures.
- Conditions
- Femoral Fracture
- Being tested
- PENG Block
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
Patient will be placed in the supine position and the ultrasound probe will be placed in the transverse plane over the anterior inferior iliac spine (AIIS) and aligned with the pubic ramus by rotating the probe counterclockwise by approximately 45 degrees. A 22-gauge, 100 mm needle will be inserted using the plane approach from lateral to medial, between the psoas tendon anteriorly and the pubic ramus posteriorly. Following a negative aspiration, 20 mL of 0.375% ropivacaine will be injected. The needle position will be confirmed by visualizing the separation of layers with the dispersion of the injected volume.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block | Patients will be submitted to PENG block intervention guiding by ultrasound. Receives: Procedure: PENG Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional impairment
The Short-form of Activity Measure for Post-Acute Care (AM-PAC- "6 clicks") is a measure of basic patient mobility will be used. Higher scores mean better outcomes. Minimum 6 points, maximum 26 points.
Measured: Before the intervention
Functional impairment
The Short-form of Activity Measure for Post-Acute Care (AM-PAC- "6 clicks") is a measure of basic patient mobility will be used. Higher scores mean better outcomes. Minimum 6 points, maximum 26 points.
Measured: 12 hours after intervention
Secondary outcomes (4)
Pain levels
The Numeric Rating Scale will be used to evaluate pain levels. Higher scores mean worst. outcomes. Minimum 0 point, maximum 10 points.
Measured: Before performing the PENG block
Pain levels
The Numeric Rating Scale will be used to evaluate pain levels. Higher scores mean worst. outcomes. Minimum 0 point, maximum 10 points.
Measured: 1 hour after performing the PENG block
Pain levels
The Numeric Rating Scale will be used to evaluate pain levels. Higher scores mean worst. outcomes. Minimum 0 point, maximum 10 points.
Measured: 12 hours after performing the PENG block
Opioid consumption
The total opioid consumption will be evaluated 24 hours after performing the PENG Block
Measured: 24 hours after performing the PENG Block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral FractureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840458
- Sponsor's protocol ID
- 48721715.0.0000.5461
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x.
PubMed 22150501Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
PubMed 33238043Hua H, Xu Y, Jiang M, Dai X. Evaluation of Pericapsular Nerve Group (PENG) Block for Analgesic Effect in Elderly Patients with Femoral Neck Fracture Undergoing Hip Arthroplasty. J Healthc Eng. 2022 Feb 9;2022:7452716. doi: 10.1155/2022/7452716. eCollection 2022.
PubMed 35186238
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Analgesia and Systemic Analgesia Associated With Pericapsular Nerve Block in Proximal Femoral Fractures
- ClinicalTrials.gov ID
- NCT05840458
- Acronym / sponsor ID
- 48721715.0.0000.5461
- Conditions
- Femoral Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 May 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.
Proximal femoral fractures commonly occur above 50 years and regional anesthesia could be a complement in the perioperative treatment of the patients. The use of pericapsular nerve group block (PENG Block) has been proposed to reduce pain. However, no studies have explored the efficient of the systemic analgesia associated with PENG Block in functional limitation in the preoperative period. In this sense, the main goal of this study is to evaluate the effectiveness of systemic analgesia associated with PENG Block in patients with proximal femoral fractures in the period preceding the surgical procedure.
Detailed description
Focus on functional capacity will be measured by the Activity Measure for Post-Acute Care (AM-PAC) short version of the "6 Clicks", pain intensity will be assessed using the numerical rating scale, and opioid consumption. This study will include 21 patients admitted to the Emergency Room with proximal femoral fractures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PENG Block | – | Procedure: PENG BlockPatients will be submitted to PENG block intervention guiding by ultrasound. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unilateral proximal femoral fractures admitted to the emergency room.
Key inclusion criteria (3 listed)
- patients with unilateral proximal femoral fractures admitted to the emergency room of the Hospital Sírio-Libanes,
- aged 18-105 years
- with the American Society of Anesthesiology (ASA) physical status I, II, or III.
Key exclusion criteria (3 listed)
- allergy to metamizole and/or ropivacaine
- history of mental disorders
- presence of chronic pain as assessed using the Douleur Neuropathique 4 (DN4) questionnaire
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 BlockPatient will be placed in the supine position and the ultrasound probe will be placed in the transverse plane over the anterior inferior iliac spine (AIIS) and aligned with the pubic ramus by rotating the probe counterclockwise by approximately 45 degrees. A 22-gauge, 100 mm needle will be inserted using the plane approach from lateral to medial, between the psoas tendon anteriorly and the pubic ramus posteriorly. Following a negative aspiration, 20 mL of 0.375% ropivacaine will be injected. The needle position will be confirmed by visualizing the separation of layers with the dispersion of the injected volume. | Procedure or surgery | PENG Block |
Primary outcome
Functional impairment
Time frame: Before the intervention
The Short-form of Activity Measure for Post-Acute Care (AM-PAC- "6 clicks") is a measure of basic patient mobility will be used. Higher scores mean better outcomes. Minimum 6 points, maximum 26 points.
Functional impairment
Time frame: 12 hours after intervention
The Short-form of Activity Measure for Post-Acute Care (AM-PAC- "6 clicks") is a measure of basic patient mobility will be used. Higher scores mean better outcomes. Minimum 6 points, maximum 26 points.
4 secondary outcomes
Pain levels
Time frame: Before performing the PENG block
Pain levels
Time frame: 1 hour after performing the PENG block
Pain levels
Time frame: 12 hours after performing the PENG block
Opioid consumption
Time frame: 24 hours after performing the PENG Block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 22150501Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x.
- Background: PubMed 33238043Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
- Background: PubMed 35186238Hua H, Xu Y, Jiang M, Dai X. Evaluation of Pericapsular Nerve Group (PENG) Block for Analgesic Effect in Elderly Patients with Femoral Neck Fracture Undergoing Hip Arthroplasty. J Healthc Eng. 2022 Feb 9;2022:7452716. doi: 10.1155/2022/7452716. eCollection 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fracture, run by Hospital Sirio-Libanes at 1 site in Brazil.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro P Kimachi, MD (+5511991752029, ppkimachi@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional impairment (time frame: Before the intervention). The study lists 2 primary outcomes in all. 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 NCT05840458, which also lists 4 linked publications.
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 19 Apr 2024.