NCT01527812

Brief Summary

The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
Last Updated

April 3, 2012

Status Verified

February 1, 2012

Enrollment Period

2.2 years

First QC Date

February 1, 2012

Last Update Submit

March 31, 2012

Conditions

Fractured Neck of Femur

Outcome Measures

Primary Outcomes (1)

  • Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia.

    Independent blinded observer will assess the patient in the first 30 minutes, in every 5 minute. Sensory perception will be assess by using cold spray in the area of the terminal branch of femoral nerve. We will assess the pain on passive movement of the limb (elevating 30 degree) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the patient will be positioned for spinal anaesthesia. If the threshold isn't achieved by 30 minutes, the block will be classified as failure. Additional opioid medication and/or sedation will be administered.

    The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.

Secondary Outcomes (4)

  • Sensory distribution of the nerve block.

    The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.

  • Number of needle passes

    during performing the femoral nerve block

  • Femoral nerve block onset time

    In the first 30 minutes after the femoral nerve block

  • Patient satisfaction

    After the surgery in the recovery area before the patient will be discharged to the ward.

Study Arms (3)

Above the femoral nerve

EXPERIMENTAL

In Group I we will inject the local anaesthetic below the fascia iliaca and above the femoral nerve.

Procedure: Femoral nerve block

Below the femoral nerve

EXPERIMENTAL

In Group II we will inject the local anaesthetic below the femoral nerve and above the fascia of the iliopsoas muscle.

Procedure: Femoral nerve block

Circumferential

EXPERIMENTAL

In Group III a circumferential spread will be achieved with multiple injections.

Procedure: Femoral nerve block

Interventions

Femoral nerve blockPROCEDURE

We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.

Above the femoral nerveBelow the femoral nerveCircumferential

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fractured neck of femur surgical fixation performed under spinal anaesthesia
  • ASA I to III

You may not qualify if:

  • Patient refusal
  • Coagulation disorders
  • Head injury or other associated injuries
  • Previous vascular surgery in the femoral area.
  • Loss of consciousness and signs of acute coronary syndrome
  • Mini-Mental Score \< 25 (see appendix 3)
  • Allergy to lignocaine,
  • Skin lesions/infection at site of injection
  • Sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Cork, Ireland

Location

Related Publications (1)

  • Szucs S, Morau D, Sultan SF, Iohom G, Shorten G. A comparison of three techniques (local anesthetic deposited circumferential to vs. above vs. below the nerve) for ultrasound guided femoral nerve block. BMC Anesthesiol. 2014 Jan 25;14:6. doi: 10.1186/1471-2253-14-6.

    PMID: 24460975DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Szilard Szucs, MD

    Cork University Hospital, Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Tutor in Anaesthesia

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 7, 2012

Study Start

December 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 3, 2012

Record last verified: 2012-02

Locations

IE(1)