NCT07716358

Brief Summary

Proximal femur fractures are among the most painful orthopedic injuries Adequate analgesia is essential to facilitate positioning for spinal anesthesia, reduce opioid requirements, and minimize related complications. The aim of study to compare the analgesic efficacy of preoperative ultrasound-guided Fascia Iliac Block Versus and Femoral Nerve Block in patients with proximal femur fractures prior to positioning for spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 9, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Femoral Nerve blockFascia Iliac Compartment Blockvisual analogue scale

Outcome Measures

Primary Outcomes (1)

  • Pain Control

    In patients with proximal femur fractures pain assessment was done baseline before blocks and at five minutes after blocks administration. Pain control assessment was done based on Visual Analogue Scale from 0-10.

    05 minutes

Study Arms (2)

Group A Participants who received Ultrasound Guided Femoral Nerve Block

EXPERIMENTAL

Participants in group-A were 42 which were assigned randomly and Femoral Nerve Block was done before spinal anaesthesia.

Procedure: Femoral Nerve Block

Group B Participants who received Ultrasound Guided Fascia Iliaca Block

ACTIVE COMPARATOR

Participants in group- B were 42 which were assigned randomly and Fascia Iliaca Block was done before spinal anaesthesia.

Procedure: Fascia Iliaca Nerve Block

Interventions

FNB was carried out as follows: the linear probe was kept in a "in line plane" approach to identify the femoral artery under ultrasound guidance. The triangular, hyperechoic femoral nerve was identified as being situated lateral to the femoral artery. The femoral artery was positioned next to an insulated 22 G needle. Once the needle tip was located and a negative blood aspiration was obtained, a little amount of local anesthetic (injection bupivacaine 0.25%) was administered. The remaining drug volume was injected based on weight (0.5 ml/kg) once the local anesthetic distribution was observed

Group A Participants who received Ultrasound Guided Femoral Nerve Block

The FICB was administered as described. We found the psoas muscle lateral to the femoral nerve. The iliacus fascia, which extends deep into the fascia Lata, covers it. Consequently, a double pop was felt after inserting the needle until it was between the psoas muscle and the fascia iliaca. As with the previously described method, 1 mL of the local aesthetic solution was injected, and following a negative blood aspiration, the medication disseminated beneath the fascia iliaca.

Group B Participants who received Ultrasound Guided Fascia Iliaca Block

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I\&II status patients coming for proximal femur fracture surgery

You may not qualify if:

  • Patients with history of neurological disease (Alzheimer, dementia),
  • Patients with known contraindication to regional anaesthesia (e.g., signs of infection at site of block, coagulation abnormality i.e. INR \>1.55, platelet count \<80,000)
  • Patients with ASA III and IV status and patients with Known allergy to the study drug were excluded from study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sughra Shafi Medical Complex

Chak Ninety-five North Branch, Punjab Province, 51600, Pakistan

Location

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck FracturesHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 21, 2026

Study Start

January 1, 2026

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations