Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by NHS Greater Glasgow and Clyde.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Golden Jubilee National Hospital
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00696150
First received: June 9, 2008
Last updated: June 11, 2008
Last verified: June 2008

June 9, 2008
June 11, 2008
July 2008
July 2010   (final data collection date for primary outcome measure)
percentage of patients with effective regional analgesia [ Time Frame: Induction of anaesthesia ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00696150 on ClinicalTrials.gov Archive Site
  • hospital mortality [ Time Frame: 1months after operation ] [ Designated as safety issue: Yes ]
  • sensory function in lateral cutaneous nerve [ Time Frame: 0mins, 10mins 20mins post insertion of local anaesthetic ] [ Designated as safety issue: No ]
  • sensory function of femoral nerve [ Time Frame: 0mins, 10mins, 20mins after insertion of local anesthetic ] [ Designated as safety issue: No ]
  • sensory function of obturator nerve [ Time Frame: 0mins, 10mins, 20mins after insertion of local anesthetic ] [ Designated as safety issue: No ]
  • motor function of obturator nerve [ Time Frame: 0mins, 10mins and 20minutes after insrtion of local anesthetic ] [ Designated as safety issue: No ]
  • motor function of femoral nerve [ Time Frame: 0mins,10mins and 20mins post insertion of local anesthetic ] [ Designated as safety issue: No ]
  • acute mental test scores [ Time Frame: 6hours and 24 hours post operatively ] [ Designated as safety issue: No ]
  • total morphine dose administered [ Time Frame: 6hours and 24 hours post operstively ] [ Designated as safety issue: No ]
  • day first mobilise post operatively [ Time Frame: post operatively 0-10 days ] [ Designated as safety issue: No ]
  • patient satisfaction scores [ Time Frame: 6 hours and 24hours post operatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Can the Femoral Nerve Block be Improved by Ultrasound Guidance?
Can the Use of Ultrasound to Guide the Insertion of a Needle for an Anterior Psoas Compartment Nerve Block Increase Its Efficacy in Comparison to Traditional Techniques Utilising Loss of Resistance and Nerve Stimulation?

Studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients. This study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement. The patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation will then be performed. Standard pain relief protocols will be used the operation and after the operation. After the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation. The first day the patient is able to walk on their new hip replacement will also be recorded.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)
    Use of ultrasound to guide the insertion of anterior psoas compartment block
  • Procedure: nerve stimulator
    The use of the nerve stimulator to guide insertion of the anterior psoas compartment block
  • Procedure: loss of resistance
    Use of ultrasound to guide the insertion of anterior psoas compartment block
  • Placebo Comparator: loss of resistance
    Anterior psoas compartment nerve block inserted using loss of resistance
    Intervention: Procedure: loss of resistance
  • Active Comparator: nerve stimulator
    Anterior psoas compartment nerve block inserted using nerve stimulator
    Interventions:
    • Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)
    • Procedure: nerve stimulator
  • Active Comparator: ultrasound
    Anterior psoas compartment nerve block inserted using ultrasound
    Intervention: Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
269
August 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective primary total hip arthroplasty under general anaesthesia
  • ASA<=4
  • Able to give informed consent
  • Able to cooperate with sensory and motor testing of lower limb function

Exclusion Criteria:

  • Abnormal clotting screen (coagulopathy) or thrombocytopenia (<100,000)
  • Acute mental test score of <=7 at any time pre or post operatively
  • Allergy to local anaesthetic
  • Signs, symptoms or laboratory evidence of local infection or systemic sepsis
  • No pre-existing neurological deficit (sensory or motor) affecting lower limb
  • Patients with lower limb amputations
Both
35 Years to 90 Years
No
Contact: Malcolm Watson, MBChB, MRCP, FRCA 01412116291 mwatson@doctors.org.uk
United Kingdom
 
NCT00696150
ultrasound for hip # study-1, CSO reference CAF/07/05
No
Dr Erica Packard, NHS Greater Glasgow and Clyde health board
NHS Greater Glasgow and Clyde
Golden Jubilee National Hospital
Study Chair: Malcolm watson, MB ChB FRCA NHS greater glasgow and clyde health board
NHS Greater Glasgow and Clyde
June 2008

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