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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00162630
Other study ID # HHSG-rct-04
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated September 13, 2006
Start date May 2003
Est. completion date March 2006

Study information

Verified date September 2006
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Fascia Iliaca Compartment Blockade


Locations

Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (2)

Lead Sponsor Collaborator
Hvidovre University Hospital IMK Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain relief within 3 hours
Secondary Nausea
Secondary Pain on transfer
Secondary Discomfort with block placement
See also
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