NCT02479828

Brief Summary

This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek. Half of the patients will not receive fascia iliaca compartment block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

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

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

June 10, 2015

Last Update Submit

March 11, 2019

Conditions

Chronic Hip Pain

Outcome Measures

Primary Outcomes (2)

  • Acute postsurgical pain after hip fracture surgery

    Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion.

    48 hours

  • Chronic postsurgical pain after hip fracture surgery

    3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain

    6 months

Study Arms (2)

Fascia iliaca compartment block (FICB)

ACTIVE COMPARATOR

Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca.

Drug: Fascia iliaca compartment blockDrug: RopivacaineDevice: ultrasound

Placebo (not FICB)

PLACEBO COMPARATOR

Half of the patients will not receive FICB

Drug: Placebo

Interventions

Fascia iliaca compartment blockDRUG

40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound

Fascia iliaca compartment block (FICB)
RopivacaineDRUG
Fascia iliaca compartment block (FICB)
ultrasoundDEVICE
Fascia iliaca compartment block (FICB)
PlaceboDRUG
Placebo (not FICB)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III (American Society of Anesthesiologists classification)
  • intertrochanteric fractures
  • fractures of femoral neck

You may not qualify if:

  • existing pain in hip Joint to be operated
  • cognitive or mental disorder
  • administration of analgesic drugs prior surgery
  • contraindications of spinal anesthesia
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepieion General Hospital

Athens, Voula, 16673, Greece

Location

Related Publications (1)

  • 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

Interventions

RopivacaineUltrasonography

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • MARIA DIAKOMI

    Asklepieion General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

GR(1)