Hip FracturesNCT05751291
Comparative Study to Evaluate the Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca Compartment (FIC) Block on the Postoperative Analgesic Effect in Patients Undergoing Hip Surgeries Under Spinal Anesthesia.
A study testing Bupivacaine Hydrochloride in people with Hip Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Bupivacaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Forty -Two patients above 18 years of age belonging to the American Society of Anaesthesiologists (ASA) physical status Classes I and II scheduled for hip surgery will randomly be allocated into two groups. Group A (PENG block) will receive US - guided PENG block and Group B (FIC block) will receive US - guided FIC block for postoperative pain relief.
Who cannot join
- Patient refusal.
- Patient with significant neurological, psychiatric or neuromuscular disease.
- Alcoholism.
- Drug abuse.
- Pregnancy or lactating women.
- Suspected Coagulopathy.
Show all 9Show fewer
- Morbid obesity.
- Known allergy to study medications.
- Septicemia and local infection at the block site.
Trial locations and contacts
1 site in 1 country.
Abdel Rahman H Abdel Rahman, Professor contact
About this study
Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Early surgery within 48 h of fracture has shown to decrease the complication and mortality rates.
- Conditions
- Hip Fractures
- Being tested
- Bupivacaine Hydrochloride
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Pericapsular Nerve Group (PENG) Block: 20 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane. Fascia Iliaca Compartment (FIC) Block: 20 mL of 0.25% bupivacaine will be injected until it spreads.
laterally toward the iliac spine and medially toward the femoral nerve.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A (PENG block) patients will receive PENG block under ultrasound-guided (USG) guidance using curvilinear low-frequency ultrasound probe (2-5 MHz) will initially be placed in a transverse plane over the Anterior inferior iliac spine ( AIIS ) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees to visualize the Iliopubic Eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle. A 22 Gauge needle will be inserted in-plane and the needle tip will be positioned in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. 20 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane. Receives: Drug: Bupivacaine Hydrochloride |
| Group B | Active comparator | Group B (FIC) patients will receive FIC block under USG guidance using high-frequency linear transducer (6-13 MHz) will be used to identify the femoral artery at the level of the inguinal crease. Immediately lateral and deep to the femoral artery and vein the iliopsoas muscle is overlaid by a hyperechoic fascia iliaca. The femoral nerve is seen lateral to the femoral artery wedged between the iliopsoas muscle and the fascia iliaca.
Maneuvering the transducer laterally helps to visualize the Sartorius muscle covered by its own fascia alongside the fascia iliaca. A line is drawn connecting the anterior superior iliac spine to the pubic tubercle; the needle tip is positioned at lateral third of the line under the fascia iliaca. 20 mL of 0.25% bupivacaine will be injected until it spreads laterally toward the iliac spine and medially toward the femoral nerve. Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Feb 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 Hip FracturesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Kamed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751291
- Sponsor's protocol ID
- Soh-Med-23-02-08
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
WERTHEIMER LG. The sensory nerves of the hip joint. J Bone Joint Surg Am. 1952 Apr;34-A(2):477-87. No abstract available.
PubMed 14917714GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.
PubMed 18873153Gerhardt M, Johnson K, Atkinson R, Snow B, Shaw C, Brown A, Vangsness CT Jr. Characterisation and classification of the neural anatomy in the human hip joint. Hip Int. 2012 Jan-Feb;22(1):75-81. doi: 10.5301/HIP.2012.9042.
PubMed 22344482Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
PubMed 29140962
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study to Evaluate the Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca Compartment (FIC) Block on the Postoperative Analgesic Effect in Patients Undergoing Hip Surgeries Under Spinal Anesthesia.
- ClinicalTrials.gov ID
- NCT05751291
- Acronym / sponsor ID
- Soh-Med-23-02-08
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 2 Mar 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.
Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Early surgery within 48 h of fracture has shown to decrease the complication and mortality rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Bupivacaine HydrochlorideGroup A (PENG block) patients will receive PENG block under ultrasound-guided (USG) guidance using curvilinear low-frequency ultrasound probe (2-5 MHz) will initially be placed in a transverse plane over the Anterior inferior iliac spine ( AIIS ) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees to visualize the Iliopubic Eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle. A 22 Gauge needle will be inserted in-plane and the needle tip will be positioned in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. 20 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane. |
| Group B | Active comparator | Drug: Bupivacaine HydrochlorideGroup B (FIC) patients will receive FIC block under USG guidance using high-frequency linear transducer (6-13 MHz) will be used to identify the femoral artery at the level of the inguinal crease. Immediately lateral and deep to the femoral artery and vein the iliopsoas muscle is overlaid by a hyperechoic fascia iliaca. The femoral nerve is seen lateral to the femoral artery wedged between the iliopsoas muscle and the fascia iliaca. Maneuvering the transducer laterally helps to visualize the Sartorius muscle covered by its own fascia alongside the fascia iliaca. A line is drawn connecting the anterior superior iliac spine to the pubic tubercle; the needle tip is positioned at lateral third of the line under the fascia iliaca. 20 mL of 0.25% bupivacaine will be injected until it spreads laterally toward the iliac spine and medially toward the femoral nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Forty -Two patients above 18 years of age belonging to the American Society of Anaesthesiologists (ASA) physical status Classes I and II scheduled for hip surgery will randomly be allocated into two groups. Group A (PENG block) will receive US - guided PENG block and Group B (FIC block) will receive US - guided FIC block for postoperative pain relief.
Key exclusion criteria (9 listed)
- Patient refusal.
- Patient with significant neurological, psychiatric or neuromuscular disease.
- Alcoholism.
- Drug abuse.
- Pregnancy or lactating women.
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 |
|---|---|---|
| Bupivacaine HydrochloridePericapsular Nerve Group (PENG) Block: 20 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane. Fascia Iliaca Compartment (FIC) Block: 20 mL of 0.25% bupivacaine will be injected until it spreads. laterally toward the iliac spine and medially toward the femoral nerve. | Drug | Group A, Group B |
Primary outcome
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.
Time frame: 6 months
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 14917714WERTHEIMER LG. The sensory nerves of the hip joint. J Bone Joint Surg Am. 1952 Apr;34-A(2):477-87. No abstract available.
- Background: PubMed 18873153GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.
- Background: PubMed 22344482Gerhardt M, Johnson K, Atkinson R, Snow B, Shaw C, Brown A, Vangsness CT Jr. Characterisation and classification of the neural anatomy in the human hip joint. Hip Int. 2012 Jan-Feb;22(1):75-81. doi: 10.5301/HIP.2012.9042.
- Background: PubMed 29140962Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
- Individual participant dataSharing planned: Undecided
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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.
Abdel Rahman H Abdel Rahman, Professor 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 Bupivacaine Hydrochloride in people with Hip Fractures, run by Sohag 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 1 inclusion and 9 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 2 Mar 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 Mustafa K Mohamed, Resident (01065674322, mostafakamal@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block. (time frame: 6 months). 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 NCT05751291, 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 2 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.