NCT06296758

Brief Summary

The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study.

Trial Health

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Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

February 29, 2024

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    Postoperative numerical pain rating scale (NRS) pain scores

    48 hours

  • Postoperative analgesics administered

    Postoperative opioid utilization

    48 hours

Secondary Outcomes (3)

  • Mobilization

    48 hours

  • Time to readiness for discharge

    48 hours

  • Complications

    48 hours

Study Arms (2)

SIFI local anesthesia

EXPERIMENTAL

Subjects randomized to the SiFi arm will have an ultrasound-guided suprainguinal fascia iliaca single shot block performed preoperatively in the anesthesia block room with 40ml of 0.2% ropivacaine local anesthetic. This will be reduced to 30 ml in patients under 60 kg.

Procedure: Regional anesthesia

FNB local anesthesia

ACTIVE COMPARATOR

Subjects randomized to the FNB arm will have an ultrasound-guided femoral nerve single shot block performed preoperatively in the anesthesia block room with 20ml of 0.5% ropivacaine local anesthetic. This will be reduced to 15ml in patients under 60 kg.

Procedure: Regional anesthesia

Interventions

ultrasound-guided suprainguinal fascia iliaca block with 40ml of ropivacaine local or ultrasound-guided femoral nerve block with 20ml of ropivacaine local anesthetic

FNB local anesthesiaSIFI local anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or greater
  • Having hip fracture surgery at the University of Alberta Hospital
  • Suitable for multimodal analgesia including a peripheral nerve block

You may not qualify if:

  • Contraindication to a nerve block technique
  • Refuses consent for a nerve block technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, t6g2b7, Canada

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomization will be conducted through blocked randomization with blocks of 4 according to a schedule not known to the investigators using a computerized algorithm. The attending surgeon, anesthetist, and nursing team will be blinded to the randomization assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A concealed-allocation parallel-group blinded randomized controlled clinical
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

August 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

No plan to make the individual participants data available to other researchers was made

Locations