Hip Fractures, Spinal Anesthesia, Supra-inguinal Fascia Iliaca Block
Conditions
Brief 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. 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.
Interventions
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.
Sponsors
Ghurki Trust and Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr. Namra Nadeem
Ghurki Trust Teaching Hospital
STUDY_DIRECTORProf. Dr. Leena Ayub
Ghurki Trust Teaching Hospital
STUDY_CHAIRDr. Shahid Dar
Ghurki Trust Teaching Hospital
STUDY_CHAIRDr. Umer Farooq
Ghurki Trust Teaching Hospital
STUDY_CHAIRDr. Adeel Shahid
Ghurki Trust Teaching Hospital
Outcome results
None listed