- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556614
Preoperative Supra-inguinal Fascia Iliaca Block for Positioning Analgesia in Hip Fracture Patients Undergoing Spinal Anesthesia
Preoperative Supra-inguinal Fascia Iliaca Block for Positioning Analgesia in Hip Fracture Patients Undergoing Spinal Anesthesia: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Lahore, Pakistan, 54000
- Ghurki Trust Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group: Group A
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.
|
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.
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|
No Intervention: Control Group: Group B
The control group (Group B) will receive no block, with all other treatment steps identical as the experimental group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Mean Pain scores will be assessed at baseline, perioperatively, at 12 hours, and at 24 hours.
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Collaborators and Investigators
Investigators
- Principal Investigator: Dr. Namra Nadeem, Ghurki Trust Teaching Hospital
- Study Director: Prof. Dr. Leena Ayub, Ghurki Trust Teaching Hospital
- Study Chair: Dr. Shahid Dar, Ghurki Trust Teaching Hospital
- Study Chair: Dr. Umer Farooq, Ghurki Trust Teaching Hospital
- Study Chair: Dr. Adeel Shahid, Ghurki Trust Teaching Hospital
Publications and helpful links
General 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. Anaesthesiology Intensive Therapy. 2024 Jan 1;56(1):54-60.
- Chen 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 geriatrics. 2021 Dec;21:1-8.
- McDonough CM, Harris-Hayes M, Kristensen MT, Overgaard JA, Herring TB, Kenny AM, Mangione KK. Physical therapy management of older adults with hip fracture: clinical practice guidelines linked to the International Classification of Functioning, Disability and Health From the Academy of Orthopaedic Physical Therapy and the Academy of Geriatric Physical Therapy of the American Physical Therapy Association. Journal of Orthopaedic & Sports Physical Therapy. 2021 Feb;51(2):CPG1-81.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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