Comparing ultrasound guided Femoral Nerve Block and Fascia Iliaca compartment block by a junior doctor for positioning during Spinal Anaesthesia in Femur Fracture surgery

Not yet recruiting

• Conditions: Unspecified fracture of femur,

• Registration Number: CTRI/2023/11/059514
• Lead Sponsor: SHREE KRISHNA HOSPITAL

Brief Summary

After obtaining institutional ethics committee approval and written and informed consent from patients of ASA I, II or III who will be undergoing femur fracture surgery under spinal anaesthesia will be recruited to participate in this study.



Participants will be allotted in to two groups through balanced randomization. A computer software viz. WINPEPI will be used for the randomization. The treatment allocation will be kept in a sealed opaque envelops and they will be opened after written informed consent of eligible participants. Pre anaesthetic check-up will be carried out in all patients.

Using a sealed envelope technique, patients will be randomly assigned into two groups.

- Group 1: Will receive FNB with Inj Ropivacaine 0.5% 30 ml

- Group 2: Will receive FICB with Inj Ropivacaine 0.5% 30 ml

In the procedure room, Standard monitoring- electrocardiogram, pulse oximetry and noninvasive blood pressure will be attached and baseline vitals and NRS will be noted. In the supine position and under all aseptic precautions, the block will be performed by a novice practitioner using ultrasound guidance.



**Following equipments will be required:**

A portable sterile tray containing:

- Sterile towel and gauze packs

- Sterile gloves

- Bowls containing povidone iodine

- Sterile syringes of 5ml and 10 ml

- Sterile needle 18G and 24G

- Sterile 23G quincke’s spinal needle

- Tegadum

- Spirit, Gel

- Ultrasound machine

- Local anaesthetic solution- Inj Ropivacaine 0.5%, volume 30 ml

In group 1 patient’s, the linear transducer will be placed transversely on femoral crease to locate femoral artery and nerve. Once the femoral nerve is identified and the local skin infiltration is given, the 23G spinal needle is inserted in a lateral to medial orientation and towards the femoral nerve. Once the needle tip is adjacent to the nerve, after negative aspiration for blood, 30 ml of local anaesthetic Inj Ropivacaine 0.5% injected slowly.



In group 2 patient’s, a line connecting anterior superior iliac spine and pubic symphysis will be drawn and dividing this line into thirds. The needle will be inserted 1 cm lateral to the intersection of the medial two thirds and lateral one third and local skin infiltration is given. The 23G spinal needle will be inserted and advanced perpendicular to the skin till the needle transverses both fascia lata and fascia iliaca of the thigh. After penetrating fascia iliaca, 30 ml of local anaesthetic Inj Ropivacaine 0.5% injected slowly after negative aspiration for the blood.

The time taken from the needle prick to the complete administration of drug will be recorded as the performance time of the block. The onset time of block will be noted. Patient will be assessed for any local systemic toxicity and after 20 minutes of block NRS score will be noted.



Patient will be shifted to operation theatre and NRS score will be noted again before giving position for spinal anaesthesia. Patient will be given sitting position for spinal anaesthesia after NRS score

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-28
• Study Start: 2023-11-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Adult patients aged 18-90 years.
• Patients scheduled for unilateral femur fracture surgery.
• Patients undergoing spinal anesthesia for femur fracture surgery.
• Patients who are able to provide informed consent.
• Patients with ASA status I, II and III.

Exclusion Criteria

• Patients with a known allergy to the local anesthetic agents used for the nerve blocks.
• Patient having local site infection and coagulopathy.
• Patients requiring epidural anaesthesia along with spinal anaesthesia.
• Patients undergoing surgery under general anaesthesia.
• Patients who are pregnant or breastfeeding.
• Patients with raised ICP and fixed low cardiac output state.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the ease to perform the block by a novice practitioner and To compare the NRS scores	0 minutes, 20 minutes

Secondary Outcome Measures

Name	Time	Method
To evaluate & compare the onset & duration of analgesia provided by femoral nerve block & fascia iliaca compartment block.	0 minutes, 20 minutes
Number of intrathecal needle pricks required to perform successful lumbar puncture in sitting position.	NA
To compare complications (hematoma, systemic LA toxicity and drug allergy) between both the groups	NA

Trial Locations

Locations (1)

Pramukh swami medical college; 🇮🇳 Anand, GUJARAT, India

Pramukh swami medical college

🇮🇳Anand, GUJARAT, India

Dr Madhavi Chaudhari

Principal investigator

9427084963

madhavic@charutarhealth.org