Hip FracturesNCT04945668
Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation
A study testing Modified technique for pericapsular nerve group block in people with Hip Fractures, run by Mansoura University at 1 site in Egypt.
Trial summary
Hip fracture is a challenging geriatric problem for health care professionals, especially in patients with multiple comorbidities. In patients with inoperable hip fractures secondary to severe comorbid conditions, the pain can lead to significant challenges in nursing care. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Modified technique for pericapsular nerve group 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
- Jul 2021to Oct 2021
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I, II, and III.
- Patients scheduled for elective or emergent hip fractures.
Who cannot join
- Patient refusal.
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases, bleeding, or coagulation abnormality.
- Psychiatric diseases.
- Local skin infection and sepsis at the site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Multiple trauma patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Ultrasound and Fluoroscopy-guided Technique for Treatment of Hip Pain. A Pilot Study for a Suggested Approach for Anterior Hip Denervation
Hip fracture is a challenging geriatric problem for health care professionals, especially in patients with multiple comorbidities. In patients with inoperable hip fractures secondary to severe comorbid conditions, the pain can lead to significant challenges in nursing care.
A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported.
Read the detailed description
The aim of this study is to help to target a suggested optimum landmark and determine the volume of injectate that can cover the distribution of the anterior articular branches supplying the hip joint.
The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint.
Ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline.
With the current understanding of the complex innervations of the hip joint, it is difficult to provide complete effective radiofrequency ablation to the articular branches supplying the hip joint. Chemical hip denervation using ultrasound was reported by previous case reports or series without mentioning a well-defined target point or an optimum injectate volume.
- Conditions
- Hip Fractures
- Being tested
- Modified technique for pericapsular nerve group 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.
Modified technique for pericapsular nerve group blockProcedure or surgery
with the patient in the supine position, ultrasound probe in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus. In this view, the ilio pubic eminence (IPE), the iliopsoas muscle and tendon will be observed. A spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip between the psoas tendon and the pubic ramus. Fluoroscopic image will be taken to confirm the needle tip position in the target site. Following negative aspiration, 15 ml dye will be injected in 5-mL increments while observing for adequate spread using fluoroscopy followed by 15ml local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group block | Other | combined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block Receives: Procedure: Modified technique for pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate to target a suggested optimal landmark
Is defined as the percentage of success to reach the target point for injection with needle punctures to up to 4 skin punctures.
Measured: just after skin puncture
Secondary outcomes (10)
Success rate of first skin puncture
Is defined as the number of getting the target point from the first skin puncture
Measured: just after skin puncture
The number of skin punctures:
Is defined as the total number of skin punctures for either getting the target point or not.
Measured: just after skin puncture for the block
the total number of needle passes required for obtaining the target landmark
Is defined as the total number of forward advancements of the spinal needle i.e. withdrawal and redirection without exiting the skin (sum of passes of all punctures).
Measured: just after skin puncture
The optimum volume of the injectate
Is defined as the optimum volume of the injectate to cover the target innervation area.
Measured: 30 minutes before surgery.
Pain measurement at rest
10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain.
Measured: Prior to performing of nerve block, 15, 30 minutes after block performance
Pain measurement on movement (attempted hip flexion to 15 degrees):
10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain,
Measured: Prior to performing of nerve block, 15, 30 minutes after block performance
Incidence of block failed block
Is defined as less than 50% pain relief of pain i.e. (less than 50% of VAS score is reduced after the block
Measured: 30 minutes after Local Anesthetic injection
Time for first analgesic request
the time passed from LA injection to the patient need of first analgesia
Measured: Within 24 hours after surgery
Patient satisfaction score
From zero=Poor, 1=fair, 2=good, 3=very good to 5=excellent
Measured: Within 24 hours after the nerve block
Complications:
presence or absence of unintentional vascular puncture, hematoma formation, parasthesia
Measured: Within 24 hours after the nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
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.
- More trials run by Mansoura 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
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Y Makharita, M.D., Study chair, Professor of Anesthesia and Surgical Intensive CareShimaa Shalaby, M.Sec., Principal investigator, Assistant lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945668
- Sponsor's protocol ID
- MFM-IRB, R.21.05.1337
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Ultrasound and Fluoroscopy-guided Technique for Treatment of Hip Pain. A Pilot Study for a Suggested Approach for Anterior Hip Denervation
- ClinicalTrials.gov ID
- NCT04945668
- Acronym / sponsor ID
- MFM-IRB, R.21.05.1337
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 30 Jun 2021 (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.
Hip fracture is a challenging geriatric problem for health care professionals, especially in patients with multiple comorbidities. In patients with inoperable hip fractures secondary to severe comorbid conditions, the pain can lead to significant challenges in nursing care.
A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported.
Detailed description
The aim of this study is to help to target a suggested optimum landmark and determine the volume of injectate that can cover the distribution of the anterior articular branches supplying the hip joint.
The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint.
Ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline.
With the current understanding of the complex innervations of the hip joint, it is difficult to provide complete effective radiofrequency ablation to the articular branches supplying the hip joint. Chemical hip denervation using ultrasound was reported by previous case reports or series without mentioning a well-defined target point or an optimum injectate volume.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group block | Other | Procedure: Modified technique for pericapsular nerve group blockcombined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I, II, and III.
- Patients scheduled for elective or emergent hip fractures.
Key exclusion criteria (8 listed)
- Patient refusal.
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases, bleeding, or coagulation abnormality.
- Psychiatric diseases.
- Local skin infection and sepsis at the site of the block.
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 |
|---|---|---|
| Modified technique for pericapsular nerve group blockwith the patient in the supine position, ultrasound probe in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus. In this view, the ilio pubic eminence (IPE), the iliopsoas muscle and tendon will be observed. A spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip between the psoas tendon and the pubic ramus. Fluoroscopic image will be taken to confirm the needle tip position in the target site. Following negative aspiration, 15 ml dye will be injected in 5-mL increments while observing for adequate spread using fluoroscopy followed by 15ml local anesthetic | Procedure or surgery | Pericapsular nerve group block |
Primary outcome
The success rate to target a suggested optimal landmark
Time frame: just after skin puncture
Is defined as the percentage of success to reach the target point for injection with needle punctures to up to 4 skin punctures.
10 secondary outcomes
Success rate of first skin puncture
Time frame: just after skin puncture
The number of skin punctures:
Time frame: just after skin puncture for the block
the total number of needle passes required for obtaining the target landmark
Time frame: just after skin puncture
The optimum volume of the injectate
Time frame: 30 minutes before surgery.
Pain measurement at rest
Time frame: Prior to performing of nerve block, 15, 30 minutes after block performance
Pain measurement on movement (attempted hip flexion to 15 degrees):
Time frame: Prior to performing of nerve block, 15, 30 minutes after block performance
Incidence of block failed block
Time frame: 30 minutes after Local Anesthetic injection
Time for first analgesic request
Time frame: Within 24 hours after surgery
Patient satisfaction score
Time frame: Within 24 hours after the nerve block
Complications:
Time frame: Within 24 hours after the nerve block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: Yes
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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.
Mohamed Y Makharita, M.D. study chair
Professor of Anesthesia and Surgical Intensive Care
Shimaa Shalaby, M.Sec. principal investigator
Assistant lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified technique for pericapsular nerve group block in people with Hip Fractures, run by Mansoura 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 8 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 30 Jun 2021. 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?
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?
The success rate to target a suggested optimal landmark (time frame: just after skin puncture). 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 30 Jun 2021.