Hip FracturesNCT05941221
Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures
A study testing pericapsular nerve group (PENG) block in people with Hip Fractures, run by Ain Shams University at 1 site in Egypt.
Trial summary
the goal of this clinical trial is to evaluate the analgesic effect of pericapsular nerve group (PENG) block in elderly patients with hip fractures undergoing hip surgery . and to evaluate its effect in reducing post operative complications . Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- pericapsular nerve group (PENG) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2023to Sep 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients must age 60 years or more .
- patients must belong to american society of anesthesiologists (ASA) classification class II or III
Who cannot join
- age < 60 years
- ASA IIII
- refusal of peripheral nerve block
- infection at the site of injection
- coagulopathy INR > 1.8
- platelets count < 50,000
- known allergy to used medications.
Trial locations and contacts
1 site in 1 country.
samuel H Daniel, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo
lydia E zakhary, 01222555128, lydia_zakhary@med.asu.edu.eg
About this study
the goal of this clinical trial is to evaluate the analgesic effect of pericapsular nerve group (PENG) block in elderly patients with hip fractures undergoing hip surgery .
and to evaluate its effect in reducing post operative complications .
Read the detailed description
all patients meeting the inclusion criteria will be informed about the study goal , methods and procedure in clear language. a written informed consent will be taken.
All patients ,once arrived to the OR, monitor will be attached, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle.
At the end of surgery,all patients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%.
- Conditions
- Hip Fractures
- Being tested
- pericapsular nerve group (PENG) block
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pericapsular nerve group (PENG) blockProcedure or surgery
patients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed . A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | patients will receive pericapsular nerve group (PENG )block through ultrasound at the end of the surgery. Receives: Procedure: pericapsular nerve group (PENG) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative analgesic effect of PENG block
evaluate the analgesic effect of PENG block in the post operative period both at rest and with movement using the Visual analog scale for pain
Measured: 24 hours
Secondary outcomes (1)
post operative complications
evaluate the effect of PENG block in reducing post operative complications like incidence of delirium using RAMSAY score
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 posted12 Jul 2023
- Study start30 Mar 2023
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia edward aziz zakhary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941221
- Sponsor's protocol ID
- pericapsular nerve group block
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.
PubMed 35933328Ying H, Chen L, Yin D, Ye Y, Chen J. Efficacy of pericapsular nerve group block vs. fascia iliaca compartment block for Hip surgeries: A systematic review and meta-analysis. Front Surg. 2023 Feb 10;10:1054403. doi: 10.3389/fsurg.2023.1054403. eCollection 2023.
PubMed 36843984
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures
- ClinicalTrials.gov ID
- NCT05941221
- Acronym / sponsor ID
- pericapsular nerve group block
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Jul 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 goal of this clinical trial is to evaluate the analgesic effect of pericapsular nerve group (PENG) block in elderly patients with hip fractures undergoing hip surgery .
and to evaluate its effect in reducing post operative complications .
Detailed description
all patients meeting the inclusion criteria will be informed about the study goal , methods and procedure in clear language. a written informed consent will be taken.
All patients ,once arrived to the OR, monitor will be attached, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle.
At the end of surgery,all patients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: pericapsular nerve group (PENG) blockpatients will receive pericapsular nerve group (PENG )block through ultrasound at the end of the surgery. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients must age 60 years or more .
- patients must belong to american society of anesthesiologists (ASA) classification class II or III
Key exclusion criteria (7 listed)
- age < 60 years
- ASA IIII
- refusal of peripheral nerve block
- infection at the site of injection
- coagulopathy INR > 1.8
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 |
|---|---|---|
| pericapsular nerve group (PENG) blockpatients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed . A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%. | Procedure or surgery | study group |
Primary outcome
post operative analgesic effect of PENG block
Time frame: 24 hours
evaluate the analgesic effect of PENG block in the post operative period both at rest and with movement using the Visual analog scale for pain
1 secondary outcome
post operative complications
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 35933328Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.
- Background: PubMed 36843984Ying H, Chen L, Yin D, Ye Y, Chen J. Efficacy of pericapsular nerve group block vs. fascia iliaca compartment block for Hip surgeries: A systematic review and meta-analysis. Front Surg. 2023 Feb 10;10:1054403. doi: 10.3389/fsurg.2023.1054403. eCollection 2023.
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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.
samuel H Daniel, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pericapsular nerve group (PENG) block in people with Hip Fractures, run by Ain Shams University at 1 site in Egypt.
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 7 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 12 Jul 2023. 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 Egypt. 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 Lydia E Zakhary, MD (00201222555128, lydia_zakhary@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative analgesic effect of PENG block (time frame: 24 hours). 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 NCT05941221, which also lists 2 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 12 Jul 2023.