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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162630
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : September 15, 2006
Sponsor:
Collaborator:
IMK Fonden
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date September 15, 2006
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
Pain relief within 3 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
  • Nausea
  • Pain on transfer
  • Discomfort with block placement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase
Official Title  ICMJE Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hip Fracture
Intervention  ICMJE Procedure: Fascia Iliaca Compartment Blockade
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 11, 2005)
48
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162630
Other Study ID Numbers  ICMJE HHSG-rct-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE IMK Fonden
Investigators  ICMJE
Study Director: Nicolai B Foss, MD Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP