Hip FracturesPhase 4NCT07556614
Preoperative Supra-inguinal Fascia Iliaca Block for Positioning Analgesia in Hip Fracture Patients Undergoing Spinal Anesthesia
A Phase 4 study testing Isobaric bupivacaine 0.5% in people with Hip Fractures and Supra-inguinal Fascia Iliaca Block, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.
Trial summary
The goal of the clinical trial is to learn if preoperative Superficial Inguinal Fascia Iliaca (SIFI) block works to reduce pain during positioning for spinal anesthesia. Investigators will compare this block to no block to see if it works to reduce procedural pain. All participants will be divided into two groups. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hip Fractures, Supra-inguinal Fascia Iliaca Block, Spinal Anesthesia
- What is being tested?
- Isobaric bupivacaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 20 Nov 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 60-80 years scheduled for hip fracture surgery under spinal anesthesia.
- ASA physical status I-III
- Patients able to provide written informed consent
Who cannot join
- Patients allergic to local anaesthetics
- Patients with pre-existing neurological diseases
- Patients with Coagulopathy or on Anticoagulants
- Patients with fractures in other body parts
- Local infection at the injection site
- Failed or inadequate block
- Conversion to General Anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Supra-inguinal Fascia Iliaca Block for Positioning Analgesia in Hip Fracture Patients Undergoing Spinal Anesthesia: A Randomized Controlled Trial
The goal of the clinical trial is to learn if preoperative Superficial Inguinal Fascia Iliaca (SIFI) block works to reduce pain during positioning for spinal anesthesia. Investigators will compare this block to no block to see if it works to reduce procedural pain. All participants will be divided into two groups. Group A will be given preoperative SIFI block prior to spinal anesthesia positioning, while Group B patients will receive no block. They will be assessed by the Visual Analogue Scale (VAS) at rest, during positioning, and at 12 and 24 hours postoperatively. Efficacy will be measured by using the VAS pain scoring system. The final assessment will be done at the 24-hour follow-up. A total of 132 patients (66 per group) fulfilling the inclusion criteria are enrolled in the study.
Read the detailed description
Hip fractures are an increasingly grave concern with an increase in geriatric global population. It has been the principal cause of morbidity in patients aged 65 \& older. The number of hip fractures is expected to rise to 4.5 million globally by the year 2050, which will pose a huge burden on the medical \& social expenditures.
Hip fractures in elderly patients prompt early surgical intervention. Spinal anaesthesia is commonly administered for hip fracture surgeries due to its advantages of minimized operative time, lesser bleeding and fewer complications. The management of these patients provides the anesthetist a great ordeal of managing a geriatric case with multiple comorbid conditions. A significant concern is the patient positioning for regional anaesthesia in a patient with restricted mobility, along with severe, excruciating pain. NSAIDS or opioids provide inadequate analgesia in addition to causing unwanted side effects and fail to reduce discomfort since it is difficult for patients with hip fractures to remain in a sitting or lateral position required for spinal anaesthesia. Effective early pain management, beginning in the Emergency department is pivotal to improving patient comfort, thereby mitigating physiological stress responses and facilitating a multimodal analgesic regimen.
The ultrasound-guided suprainguinal fascia iliaca compartment block (SIFI block) is a regional anesthesia technique that targets the femoral, lateral femoral cutaneous, and obturator nerves, providing profound analgesia for hip fractures.
Limited research exists on ultrasound-guided emergency SIFI blocks for hip fracture patients, with inconclusive data about functional outcomes such as VAS scores in tertiary care hospital patients. The foundation of this research is to investigate whether including ultrasound-guided SIFI block through emergency protocols for hip fracture patients will create measurable improvements in patient positioning and extend analgesic duration while improving both patient recovery and satisfaction.
- Being tested
- Isobaric bupivacaine 0.5%
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isobaric bupivacaine 0.5%Drug
Patients in the intervention group (A) will receive a preoperative supra-inguinal fascia Iliaca block. Under aseptic conditions, a high-frequency linear ultrasound probe (8-12 MHz) will be positioned at the anterior superior iliac spine (ASIS) and directed medially in an hourglass pattern. A short-beveled Sonoplex needle will be inserted in-plane through the sartorius muscle towards the fascia iliaca. Following hydro-dissection with 4-5 mL of normal saline to confirm the correct needle placement, 30 mL of 0.25% bupivacaine will be administered. Appropriate spread will be confirmed by the separation of the fascia iliaca from the iliacus muscle, and sensory coverage over the lateral, medial, and anterior thigh will be checked with cold saline. Spinal anesthesia will be performed using a 25-gauge. Quinke spinal needle at the L2-L4 level, with 1.5-2 mL of 0.5% isobaric bupivacaine. After the procedure, patients will be repositioned supine, and surgery will proceed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Group A | Experimental | Patients in the intervention group (A) will receive a preoperative supra-inguinal fascia Iliaca block. Under aseptic conditions, a high-frequency linear ultrasound probe (8-12 MHz) will be positioned at the anterior superior iliac spine (ASIS) and directed medially in an hourglass pattern. A short-beveled Sonoplex needle will be inserted in-plane through the sartorius muscle towards the fascia iliaca. Following hydro-dissection with 4-5 mL of normal saline to confirm the correct needle placement, 30 mL of 0.25% bupivacaine will be administered. Appropriate spread will be confirmed by the separation of the fascia iliaca from the iliacus muscle, and sensory coverage over the lateral, medial, and anterior thigh will be checked with cold saline. Spinal anesthesia will be performed using a 25-gauge Quinke spinal needle at the L2-L4 level, with 1.5-2 mL of 0.5% isobaric bupivacaine. Receives: Drug: Isobaric bupivacaine 0.5% |
| Control Group: Group B | No intervention | The control group (Group B) will receive no block, with all other treatment steps identical as the experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
VAS is a psychometric measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured, such as pain intensity. It consists of a horizontal line, 10 cm in length, anchored at each end with descriptors representing the extremes of the sensation being measured ('no pain' to 'worst imaginable pain'). The VAS score is determined by measuring in millimeters from the left-hand end of the line (no pain) to the point that the patient marks representing their perceived level of pain, yielding a value from 0 to 100. Pain scores will be assessed at rest, during positioning, and at 12 hours and 24 hours.
Measured: Mean Pain scores will be assessed at baseline, perioperatively, at 12 hours, and at 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jun 2025
- Primary completion15 Nov 2025
- Study completion20 Nov 2025
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghurki Trust and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Namra Nadeem, Principal investigator, Ghurki Trust Teaching HospitalProf. Dr. Leena Ayub, Study director, Ghurki Trust Teaching HospitalDr. Shahid Dar, Study chair, Ghurki Trust Teaching HospitalDr. Umer Farooq, Study chair, Ghurki Trust Teaching HospitalDr. Adeel Shahid, Study chair, Ghurki Trust Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556614
- Sponsor's protocol ID
- R-30
- Status last verified
- Feb 2026
- First submitted
- 7 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahithi TO, Venkatraman RA, Swetharamani CK, Karthik KR. Evaluation of ultrasound-guided pre-emptive fascia iliaca compartment block for postoperative analgesia in femur and hip fracture surgeries: a randomised controlled trial. J Clin Diagnostic Res. 2022 Jun 1;16:UC29-32.
Ali FM, Ayub A, Darlong V, Pandey RK, Punj J, Sharma V. Ultrasound-guided suprainguinal fascia iliaca block to position the patient for neuraxial anaesthesia in acetabular surgery - a randomized controlled pilot study. Anaesthesiol Intensive Ther. 2024;56(1):54-60. doi: 10.5114/ait.2024.138554.
PubMed 38741444Chen L, Shen Y, Liu S, Cao Y, Zhu Z. Ultrasound-guided supra-inguinal fascia Iliaca compartment block for older adults admitted to the emergency department with hip fracture: a randomized controlled, double-blind clinical trial. BMC Geriatr. 2021 Dec 1;21(1):669. doi: 10.1186/s12877-021-02646-4.
PubMed 34852764McDonough CM, Harris-Hayes M, Kristensen MT, Overgaard JA, Herring TB, Kenny AM, Mangione KK. Physical Therapy Management of Older Adults With Hip Fracture. J Orthop Sports Phys Ther. 2021 Feb;51(2):CPG1-CPG81. doi: 10.2519/jospt.2021.0301.
PubMed 33522384
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Supra-inguinal Fascia Iliaca Block for Positioning Analgesia in Hip Fracture Patients Undergoing Spinal Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07556614
- Acronym / sponsor ID
- R-30
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ghurki Trust and Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 29 Apr 2026 (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 the clinical trial is to learn if preoperative Superficial Inguinal Fascia Iliaca (SIFI) block works to reduce pain during positioning for spinal anesthesia. Investigators will compare this block to no block to see if it works to reduce procedural pain. All participants will be divided into two groups. Group A will be given preoperative SIFI block prior to spinal anesthesia positioning, while Group B patients will receive no block. They will be assessed by the Visual Analogue Scale (VAS) at rest, during positioning, and at 12 and 24 hours postoperatively. Efficacy will be measured by using the VAS pain scoring system. The final assessment will be done at the 24-hour follow-up. A total of 132 patients (66 per group) fulfilling the inclusion criteria are enrolled in the study.
Detailed description
Hip fractures are an increasingly grave concern with an increase in geriatric global population. It has been the principal cause of morbidity in patients aged 65 \& older. The number of hip fractures is expected to rise to 4.5 million globally by the year 2050, which will pose a huge burden on the medical \& social expenditures.
Hip fractures in elderly patients prompt early surgical intervention. Spinal anaesthesia is commonly administered for hip fracture surgeries due to its advantages of minimized operative time, lesser bleeding and fewer complications. The management of these patients provides the anesthetist a great ordeal of managing a geriatric case with multiple comorbid conditions. A significant concern is the patient positioning for regional anaesthesia in a patient with restricted mobility, along with severe, excruciating pain. NSAIDS or opioids provide inadequate analgesia in addition to causing unwanted side effects and fail to reduce discomfort since it is difficult for patients with hip fractures to remain in a sitting or lateral position required for spinal anaesthesia. Effective early pain management, beginning in the Emergency department is pivotal to improving patient comfort, thereby mitigating physiological stress responses and facilitating a multimodal analgesic regimen.
The ultrasound-guided suprainguinal fascia iliaca compartment block (SIFI block) is a regional anesthesia technique that targets the femoral, lateral femoral cutaneous, and obturator nerves, providing profound analgesia for hip fractures.
Limited research exists on ultrasound-guided emergency SIFI blocks for hip fracture patients, with inconclusive data about functional outcomes such as VAS scores in tertiary care hospital patients. The foundation of this research is to investigate whether including ultrasound-guided SIFI block through emergency protocols for hip fracture patients will create measurable improvements in patient positioning and extend analgesic duration while improving both patient recovery and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Group A | Experimental | Drug: Isobaric bupivacaine 0.5%Patients in the intervention group (A) will receive a preoperative supra-inguinal fascia Iliaca block. Under aseptic conditions, a high-frequency linear ultrasound probe (8-12 MHz) will be positioned at the anterior superior iliac spine (ASIS) and directed medially in an hourglass pattern. A short-beveled Sonoplex needle will be inserted in-plane through the sartorius muscle towards the fascia iliaca. Following hydro-dissection with 4-5 mL of normal saline to confirm the correct needle placement, 30 mL of 0.25% bupivacaine will be administered. Appropriate spread will be confirmed by the separation of the fascia iliaca from the iliacus muscle, and sensory coverage over the lateral, medial, and anterior thigh will be checked with cold saline. Spinal anesthesia will be performed using a 25-gauge Quinke spinal needle at the L2-L4 level, with 1.5-2 mL of 0.5% isobaric bupivacaine. |
| Control Group: Group B | No intervention | –The control group (Group B) will receive no block, with all other treatment steps identical as the experimental group |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 60-80 years scheduled for hip fracture surgery under spinal anesthesia.
- ASA physical status I-III
- Patients able to provide written informed consent
Key exclusion criteria (7 listed)
- Patients allergic to local anaesthetics
- Patients with pre-existing neurological diseases
- Patients with Coagulopathy or on Anticoagulants
- Patients with fractures in other body parts
- Local infection at the injection site
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 |
|---|---|---|
| Isobaric bupivacaine 0.5%Patients in the intervention group (A) will receive a preoperative supra-inguinal fascia Iliaca block. Under aseptic conditions, a high-frequency linear ultrasound probe (8-12 MHz) will be positioned at the anterior superior iliac spine (ASIS) and directed medially in an hourglass pattern. A short-beveled Sonoplex needle will be inserted in-plane through the sartorius muscle towards the fascia iliaca. Following hydro-dissection with 4-5 mL of normal saline to confirm the correct needle placement, 30 mL of 0.25% bupivacaine will be administered. Appropriate spread will be confirmed by the separation of the fascia iliaca from the iliacus muscle, and sensory coverage over the lateral, medial, and anterior thigh will be checked with cold saline. Spinal anesthesia will be performed using a 25-gauge. Quinke spinal needle at the L2-L4 level, with 1.5-2 mL of 0.5% isobaric bupivacaine. After the procedure, patients will be repositioned supine, and surgery will proceed. | Drug | Intervention Group: Group A |
Primary outcome
Visual Analogue Scale
Time frame: Mean Pain scores will be assessed at baseline, perioperatively, at 12 hours, and at 24 hours.
VAS is a psychometric measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured, such as pain intensity. It consists of a horizontal line, 10 cm in length, anchored at each end with descriptors representing the extremes of the sensation being measured ('no pain' to 'worst imaginable pain'). The VAS score is determined by measuring in millimeters from the left-hand end of the line (no pain) to the point that the patient marks representing their perceived level of pain, yielding a value from 0 to 100. Pain scores will be assessed at rest, during positioning, and at 12 hours and 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 29 Apr 2026.
- BackgroundSahithi TO, Venkatraman RA, Swetharamani CK, Karthik KR. Evaluation of ultrasound-guided pre-emptive fascia iliaca compartment block for postoperative analgesia in femur and hip fracture surgeries: a randomised controlled trial. J Clin Diagnostic Res. 2022 Jun 1;16:UC29-32.
- Background: PubMed 38741444Ali FM, Ayub A, Darlong V, Pandey RK, Punj J, Sharma V. Ultrasound-guided suprainguinal fascia iliaca block to position the patient for neuraxial anaesthesia in acetabular surgery - a randomized controlled pilot study. Anaesthesiol Intensive Ther. 2024;56(1):54-60. doi: 10.5114/ait.2024.138554.
- Background: PubMed 34852764Chen L, Shen Y, Liu S, Cao Y, Zhu Z. Ultrasound-guided supra-inguinal fascia Iliaca compartment block for older adults admitted to the emergency department with hip fracture: a randomized controlled, double-blind clinical trial. BMC Geriatr. 2021 Dec 1;21(1):669. doi: 10.1186/s12877-021-02646-4.
- Background: PubMed 33522384McDonough CM, Harris-Hayes M, Kristensen MT, Overgaard JA, Herring TB, Kenny AM, Mangione KK. Physical Therapy Management of Older Adults With Hip Fracture. J Orthop Sports Phys Ther. 2021 Feb;51(2):CPG1-CPG81. doi: 10.2519/jospt.2021.0301.
- Individual participant dataSharing planned: No
Related trials for Hip Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
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.
Dr. Namra Nadeem principal investigator
Ghurki Trust Teaching Hospital
Prof. Dr. Leena Ayub study director
Ghurki Trust Teaching Hospital
Dr. Shahid Dar study chair
Ghurki Trust Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isobaric bupivacaine 0.5% in people with Hip Fractures and Supra-inguinal Fascia Iliaca Block, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 29 Apr 2026. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual Analogue Scale (time frame: Mean Pain scores will be assessed at baseline, perioperatively, at 12 hours, and at 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 NCT07556614, 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 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.