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

NCT07221682 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202/IRB/SLMC/SWL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Analgesia; Bradycardia; Hypotension Drug-Induced

Keywords

S-FICB; I-FICB; ASA; EOSP

Outcome Measures

Primary Outcomes (1)

• Ease of Spinal Positioning

  The ease of spinal positioning (EOSP) will be assessed on the scale of 0-3 0= unable to position 1. patient had abnormal posturing due to pain and required support for positioning 2. mild discomfort but does not require support for positioning 3. optimal condition where the patient was able to position himself without pain

  From performance of block to spinal anesthesia procedure begins

Secondary Outcomes (1)

• Post Op Analgesia

  From Performance of Block to First Rescue Analgesia e.g. at 0,2,4,6 upto 12 hours

Study Arms (2)

GROUP S-FICB

OTHER

Suprainguinal Facia Iliaca Block

Drug: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK

GROUP I-FICB

OTHER

Infrainguinal Facia Iliaca Block

Drug: USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK

Interventions

USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK DRUG

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.

Also known as: Sifi-B

GROUP S-FICB

USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK DRUG

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.

Also known as: Iifi-B

GROUP I-FICB

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead

Study Sites (1)

Sahiwal Medical College Sahwal

Sāhīwāl, Punjab Province, 57000, Pakistan

RECRUITING

MeSH Terms

Conditions

Bradycardia; Hypotension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Adeel Riaz, MD

  Sahiwal medical college sahiwal

  STUDY DIRECTOR

Central Study Contacts

Dr Humaira Shahzadi, MBBS

CONTACT

00923044128425; humairaali2323@gmail.com

Dr Muhammad Shahid, FCPS

CONTACT

00923336173056; shahidnishtar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group 1 will receive S-FICB and Group 2 will receive I-FICB

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 28, 2025
• Study Start: May 6, 2024
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: November 2025
• Access Criteria: On Demand

Locations

PA (1)