Fascia Iliaca Compartment Blockade as Analgesia for Hip F... | NCT00162630

Studies
Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase

NCT00162630

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Sep 15, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Hip Fracture

Interventions

Fascia Iliaca Compartment Blockade

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2006

Last Update Posted Date

Sep 15, 2006Estimated

Name	Class
IMK Fonden	OTHER

Description Module

Brief Summary

To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with local anaesthetics in patients with hip fracture immediately after arrival in the emergency department.

Detailed Description

Hip fracture patients have severe pain in the acute phase. Traditional analgesic treatment have consisted of intramuscular morphine with its associated side effects. The trial evaluates the Fascia iliaca compartment compared to regular opioid pain therapy in hip fracture patinets immediately after arrival at the emergency department.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Fascia Iliaca Compartment Blockade	Procedure

Measure	Description	Time Frame
Pain relief within 3 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary hip fracture suspected
able to give informed consent
no substance abuse
no regular opioid therapy
no opioid treatment within the last 6 hours
morphine intolerance
allergies to local anaesthetics

Exclusion Criteria:

Fracture ruled out on x-ray

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolai B Foss, MD	Hvidovre University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Hvidovre		2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33238043	Derived	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.

ID	Term
D006620	Hip Fractures
D010146	Pain
D000377	Agnosia

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries