Preoperative Supra-inguinal Fascia Iliaca Block for Positioning Analgesia in Hip Fracture Patients Undergoing Spinal Anesthesia

NCT07556614 | Completed Phase 4 DMC

• 1 other identifier: R-30
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Supra-inguinal Fascia Iliaca Block; Spinal Anesthesia; Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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.

  Mean Pain scores will be assessed at baseline, perioperatively, at 12 hours, and at 24 hours.

Study Arms (2)

Intervention Group: Group A

EXPERIMENTAL

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.

Drug: Isobaric bupivacaine 0.5%

Control Group: Group B

NO INTERVENTION

The control group (Group B) will receive no block, with all other treatment steps identical as the experimental group

Interventions

Isobaric bupivacaine 0.5% DRUG

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.

Intervention Group: Group A

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ghurki Trust and Teaching Hospital: lead

Study Sites (1)

Ghurki Trust Teaching Hospital

Lahore, 54000, Pakistan

Location

Related Publications (4)

• Sahithi TO, Venkatraman RA, Swetharamani CK, Karthik KR. Evaluation of ultrasound-guided pre-emptive fascia iliaca compartment block for postoperative analgesia in femur and hip fracture surgeries: a randomised controlled trial. J Clin Diagnostic Res. 2022 Jun 1;16:UC29-32.

  BACKGROUND

• Ali FM, Ayub A, Darlong V, Pandey RK, Punj J, Sharma V. Ultrasound-guided suprainguinal fascia iliaca block to position the patient for neuraxial anaesthesia in acetabular surgery-a randomized controlled pilot study. Anaesthesiology Intensive Therapy. 2024 Jan 1;56(1):54-60.

  BACKGROUND

• Chen L, Shen Y, Liu S, Cao Y, Zhu Z. Ultrasound-guided supra-inguinal fascia Iliaca compartment block for older adults admitted to the emergency department with hip fracture: a randomized controlled, double-blind clinical trial. BMC geriatrics. 2021 Dec;21:1-8.

  BACKGROUND

• McDonough CM, Harris-Hayes M, Kristensen MT, Overgaard JA, Herring TB, Kenny AM, Mangione KK. Physical therapy management of older adults with hip fracture: clinical practice guidelines linked to the International Classification of Functioning, Disability and Health From the Academy of Orthopaedic Physical Therapy and the Academy of Geriatric Physical Therapy of the American Physical Therapy Association. Journal of Orthopaedic & Sports Physical Therapy. 2021 Feb;51(2):CPG1-81.

  BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Dr. Namra Nadeem

  Ghurki Trust Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Dr. Leena Ayub

  Ghurki Trust Teaching Hospital

  STUDY DIRECTOR

• Dr. Shahid Dar

  Ghurki Trust Teaching Hospital

  STUDY CHAIR

• Dr. Umer Farooq

  Ghurki Trust Teaching Hospital

  STUDY CHAIR

• Dr. Adeel Shahid

  Ghurki Trust Teaching Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 29, 2026
• Study Start: June 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 20, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)