Comparison of the Analgesic Effect of Ultrasound-Guided Suprainguinal Fascia Iliaca Block (SIFI) Versus Femoral Nerve Block (FNB) for Positioning During Central Neuraxial Block in Patients Undergoing Proximal Femur Fracture Surgery: A Double-Blinded Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To compare the analgesic effect of ultrasound guided suprainguinal fascia iliaca block versus femoral nerve block using Numerical Rating Scale (NRS) at rest for performing central neuraxial block in patients undergoing proximal femur fracture surgery.
Overview
Brief Summary
This study is a double-blinded, randomized controlled trial on proximal femur fracture patients after ethical clearance and informed consent. Patients are randomized into two groups (SIFI block vs. femoral nerve block) using computer-generated numbers and sealed envelopes. A thorough preoperative evaluation, investigations, and counseling regarding the procedure are performed. Standard fasting guidelines and prophylactic medications are followed.
Intraoperatively, patients are monitored with ASA standard monitors, and baseline parameters are recorded. Group A receives an ultrasound-guided suprainguinal fascia iliaca block with 30 ml 0.2% ropivacaine + dexamethasone, while Group B receives an ultrasound-guided femoral nerve block with 20 ml 0.2–0.25% ropivacaine + dexamethasone. Pain (NRS) and hemodynamic parameters are assessed up to 20 minutes post-block. Rescue fentanyl is administered if NRS >4.
Central neuraxial blockade follows: an epidural catheter is placed at L2/L3 and tested with lignocaine-adrenaline, followed by spinal anesthesia at L3/L4 using 0.5% heavy bupivacaine. Adequate analgesia (paracetamol) and hemodynamic stability are ensured. Post-surgery, patients are shifted to HDU for monitoring and pain management.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Elective procedures of proximal femur fracture surgeries under central blockage
- •Patients belonging American Society of Anaesthesiologist (ASA) physical status of l- lll.
Exclusion Criteria
- •Inability to comprehend Numerical Rating Score
- •Patients with Coagulopathies
- •Patients on treatment for chronic pain.
Outcomes
Primary Outcomes
To compare the analgesic effect of ultrasound guided suprainguinal fascia iliaca block versus femoral nerve block using Numerical Rating Scale (NRS) at rest for performing central neuraxial block in patients undergoing proximal femur fracture surgery.
Time Frame: Numerical rating scale (NRS)pain measured at Rest ,15 degree passive leg raise at 5,10,15,20 minutes before spinal anaesthesia .
Secondary Outcomes
- 1)The pain using Numerical Rating Scale at the time of positioning between the 2 groups.(2)The hemodynamic parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure, Oxygen saturation) pre-intervention, from the time of nerve block till central neuraxial block between the 2 groups.)
Investigators
Swathi M
pondicherry institute of medical science