NCT02037633

Brief Summary

The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

January 12, 2014

Last Update Submit

January 15, 2014

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

  • Pain scores on the Numeric Rating Scale

    Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)

Secondary Outcomes (2)

  • Duration of spinal anesthesia performance

    Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)

  • Quality of patient's position

    Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)

Study Arms (2)

Fascia iliaca compartment block

ACTIVE COMPARATOR
Procedure: Fascia iliaca compartment blockDrug: ropivacaine

Fentanyl

ACTIVE COMPARATOR
Drug: Fentanyl

Interventions

FentanylDRUG

Fentanyl IV

Fentanyl
Fascia iliaca compartment blockPROCEDURE

Fascia iliaca compartment block using ropivacaine

Fascia iliaca compartment block
ropivacaineDRUG
Fascia iliaca compartment block

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hip fracture

You may not qualify if:

  • contraindications for central nervous blockade
  • impaired cognition or dementia
  • multiple fractures
  • any previous analgesic administration during the last 12 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepieion Hospital of Voula

Athens, Attica, 16673, Greece

Location

Related Publications (3)

  • Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22.

    PMID: 19650803BACKGROUND

  • Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.

    PMID: 18762870BACKGROUND

  • Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

FentanylRopivacaine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 12, 2014

First Posted

January 16, 2014

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

GR(1)