Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery (27G)

Comparison For Ease Of Spinal Positioning & Duration Of Post-Op Analgesia Between Ultrasound Guided Supra-Inguinal Fascia Iliaca Block Vs Ultrasound Guided Infra-Inguinal Fascia Iliaca Block In Patients Undergoing Thigh & Knee Surgeries

Severe pain associated with thigh and knee fractures makes the positioning for regional anesthesia a challenge. Different modalities to make patient pain free for spinal positioning, post op analgesia and patient satisfaction including supra-inguinal fascia iliaca block (S-FIB) and infra-inguinal fascia iliaca blocks (I-FIB) have been studies. The aim of this study is to compare two blocks in patients undergoing thigh and knee surgeries.

A randomized controlled trial study design will be used and 60 patients fulfilling the inclusion criteria will be included. The patients will be divided into 2 groups by simple random sampling. Group A (S-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine) and Group B (I-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine). Depending on the allotted group, patients will be given the block under the guidance of ultrasound in the preoperative area. After block patients will be assessed for ease of spinal positioning using EOSP Scale, postoperative duration of analgesia and patient satisfaction using Likert Scale and data will be recorded on prescribed proforma.

All the findings will be noted in a specially designed proforma by the researcher. All the data collected will be entered and analyzed. Quantitative variables will be presented with mean ± SD. Independent sample t-test for duration of postoperative analgesia. Qualitative variables such as ease of spinal positioning and gender will be presented with Chi-Square. A p-value equal to or less than 0.05 will be considered significant.

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Post Operative Analgesia; Hypotension Drug-Induced
• Intervention / Treatment: Drug: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK; Drug: USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK

Detailed Description

Patients fulfilling the inclusion criteria will be included. Patients will be optimized for dressing. A detailed history will be taken regarding the mode of injury, any pre-existing disease and previous surgery followed by the local examination of the patient will be done to rule out any systemic disease. Informed consent will be taken. These patients will be divided into 2 groups by Computer-generated random numbers and group assignment will be done by sequentially numbered opaque envelopes. The envelope will be opened just before the procedure by the anaesthesiologist performing the block. The observer (another anaesthesiologist) and patients will be unaware of the group and procedure performed. Group A (Supra-inguinal Fascia Iliaca Block) and Group B (Infra-inguinal Fascia Iliaca Block). The monitors of electrocardiogram, pulse oximetry and non-invasive blood pressure in induction room will be connected. For drug and fluid administration, an intravenous cannula of suitable size will be obtained. Pre-procedural pain will be assessed during rest as well as on movement (15° passive elevation) of the affected limb and will be recorded on numeric pain rating scale (NRS) [0 = no pain; 10 = worst imaginable pain]. The blocks will be performed in supine position and strict sterile technique will be followed. Both the blocks will be performed as per the standard technique. The site to be blocked will be painted with 5% povidone-iodine followed by spirit and will be draped. A linear 7-13 mhz ultrasonography probe (sonoscape S 11plus, digital colour doppler ultrasound., Guangdong, China) will be used with in-plane approach of needle. Group A (S-FIB) (n = 30, those who will receive a S-FIB with 30 ml of 0.125% bupivacaine) and group B (I-FIB) (n = 30, those who will receive a I-FIB with 30 ml of 0.125% bupivacaine). Depending on the allotted group, patients will be given the block under the guidance of ultrasound in the preoperative area by an experienced anesthesiologist with more than two years' experience. The S-FIB will be given as follows: With the patient in the proper position, the skin will be disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer will be moved laterally until the sartorius muscle is identified. The needle entry point will be anaesthetized with 2 ml 1% lidocaine and 23G spinal needle will be inserted. After negative aspiration, 1-2 ml of Inj Bupivacain 0.125% will be injected to confirm the proper injection plane between the fascia and the ilio-psoas muscle. A proper injection will result in the separation of the fascia iliaca by the local anesthetic in the medial-lateral direction from the point of injection as described. After the spread of the drug will be seen, the rest of the drug volume will be injected.

The I-FIB will be given in similar manner. In ultrasound guided I-FIB technique, a high frequency linear probe will be placed transversely at the level of the inguinal crease. After the femoral artery is identified, the probe will be moved laterally, and the hypoechoic iliopsoas muscle will be identified which is covered by the hyperechoic fascia iliaca. This fascia invests the femoral nerve medially and laterally covers the sartorius muscle. A needle will be inserted in-plane from lateral to medial and pierces the fascia iliaca at the junction of medial border of sartorius and iliopsoas muscle. Then Inj Bupivacain 0.125% will be deposited deep to fascia iliaca and will be seen spreading toward the femoral nerve medially.

A numerical rating scale (NRS) pain score will be recorded after the block. The onset time to achieve NRS pain score of 4 or less than 4 will be noted on prescribed proforma for both groups. The patients will be made to sit for spinal anesthesia and ease of spinal positioning according to the scale (0,1,2,3) , will be noted after preloading with ringer lactate solution @80ml/kg. The spinal anaesthesia will be performed using 27G spinal needle (Quincke) with 0.75% bupivacaine solution (2ml) in both groups. The monitors of electrocardiogram, pulse oximetry, non-invasive blood pressure and urine output will be monitored according to ASA standard. After completion of surgery patient will be shifted to respective ward where trained doctor and staff will monitor the patient. The NRS score will be measured immediately postoperatively and at intervals of 2 hours for a period of 12 hours. If the NRS score will be >4, rescue analgesia will be given; an injection of paracetamol 15 mg/kg will be given over a period of 10 to 15 minutes as an intravenous infusion. Inj nalbuphine 0.1mg/kg will be given for breakthrough pain. Total dose of intravenous nalbuphine will be recorded in 1st 12hrs. Patient satisfaction will be measured on a 1-5 Likert Scale after 12 hours.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Dr Muhammad Shahid, FCPS; Phone Number: 00923336173056; Email: shahidnishtar@gmail.com
• Study Contact Backup: Name: Dr Humaira Shahzadi, MBBS; Phone Number: 00923044128425; Email: humairaali2323@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Sāhīwāl, Punjab Province, Pakistan, 57000
      • Recruiting
      • Sahiwal Medical College Sahwal
      • Contact: Dr Rao Riaz ul-Haq, FCPS; Phone Number: 0092404502470; Email: slmcswl@gmail.com
      • Principal Investigator: Dr Humaira Shahzadi, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Both Genders (Male /Female).
2. Age between 30 years to 60 years.
3. ASA Class I, II, III.

Exclusion Criteria:

1. Patient refusal
2. Other distracting painful pathology
3. Any contraindication to Spinal Anesthesia or peripheral nerve blocks
4. Coagulopathic disorders
5. Patients with significant cognitive impairment
6. Patients with no pain while sitting by themselves without any support
7. H/O polytrauma involving other limbs
8. H/O allergy to the drugs used in study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GROUP S-FICB; Suprainguinal Facia Iliaca Block	Drug: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK; The S-FICB will be given as follows: With the patient in the proper position, the skin will be disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer will be moved laterally until the sartorius muscle is identified. The needle entry point will be anaesthetized with 2 ml 1% lidocaine and 23G spinal needle will be inserted. After negative aspiration, 1-2 mL of Inj Bupivacain 0.125% will be injected to confirm the proper injection plane between the fascia and the ilio-psoas muscle. A proper injection will result in the separation of the fascia iliaca by the local anesthetic in the medial-lateral direction from the point of injection as described. After the spread of the drug will be seen, the rest of the drug volume will be injected.; Other Names: Sifi-B
Other: GROUP I-FICB; Infrainguinal Facia Iliaca Block	Drug: USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK; The I-FICB will be given in similar manner. In ultrasound guided I-FICB technique, a high frequency linear probe will be placed transversely at the level of the inguinal crease. After the femoral artery is identified, the probe will be moved laterally, and the hypoechoic iliopsoas muscle will be identified which is covered by the hyperechoic fascia iliaca. This fascia invests the femoral nerve medially and laterally covers the sartorius muscle. A needle will be inserted in-plane from lateral to medial and pierces the fascia iliaca at the junction of medial border of sartorius and iliopsoas muscle. Then Inj Bupivacain 0.125% will be deposited deep to fascia iliaca and will be seen spreading toward the femoral nerve medially.; Other Names: Iifi-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Spinal Positioning	The ease of spinal positioning (EOSP) will be assessed on the scale of 0-3 0= unable to position; patient had abnormal posturing due to pain and required support for positioning; mild discomfort but does not require support for positioning; optimal condition where the patient was able to position himself without pain	From performance of block to spinal anesthesia procedure begins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Op Analgesia	Duration of Post Op Analgesia	From Performance of Block to First Rescue Analgesia e.g. at 0,2,4,6 upto 12 hours

Collaborators and Investigators

• Sponsor: Sahiwal medical college sahiwal
• Investigators: Study Director: Adeel Riaz, MD, Sahiwal medical college sahiwal

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 21, 2025
• First Submitted That Met QC Criteria: October 25, 2025
• First Posted (Actual): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ASA; S-FICB; I-FICB; EOSP
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Hypotension; Bradycardia
• Other Study ID Numbers: 202/IRB/SLMC/SWL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available on request after completion of study
• IPD Sharing Time Frame: November 2025
• IPD Sharing Access Criteria: On Demand
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No