Can the Femoral Nerve Block be Improved by Ultrasound Guidance? - Full Text View

Sponsors and Collaborators:	NHS Greater Glasgow and Clyde Golden Jubilee National Hospital
Information provided by:	NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:	NCT00696150

Purpose

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.

Condition	Intervention	Phase
Pain	Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator) Procedure: nerve stimulator Procedure: loss of resistance	Phase IV

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	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?

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:

percentage of patients with effective regional analgesia [ Time Frame: Induction of anaesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	269
Study Start Date:	July 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
loss of resistance: Placebo Comparator Anterior psoas compartment nerve block inserted using loss of resistance	Procedure: loss of resistance Use of ultrasound to guide the insertion of anterior psoas compartment block
nerve stimulator: Active Comparator Anterior psoas compartment nerve block inserted using nerve stimulator	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
ultrasound: Active Comparator Anterior psoas compartment nerve block inserted using ultrasound	Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator) Use of ultrasound to guide the insertion of anterior psoas compartment block

Eligibility

Ages Eligible for Study:	35 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696150

Contacts

Contact: Malcolm Watson, MBChB, MRCP, FRCA

01412116291

mwatson@doctors.org.uk

Locations

United Kingdom, Lanarkshire
Gartnavel General hospital
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Golden Jubilee hospital
Glasgow, Lanarkshire, United Kingdom
Glasgow Royal Infrimary
Glasgow, Lanarkshire, United Kingdom, G4
United Kingdom, Renfrewshire
Royal alexandra hospital
Paisley, Renfrewshire, United Kingdom, PA2

Sponsors and Collaborators

NHS Greater Glasgow and Clyde

Golden Jubilee National Hospital

Investigators

Study Chair:

Malcolm watson, MB ChB FRCA

NHS greater glasgow and clyde health board

More Information

Responsible Party:	NHS Greater Glasgow and Clyde health board ( Dr Erica Packard )
Study ID Numbers:	ultrasound for hip # study-1, CSO reference CAF/07/05
Study First Received:	June 9, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00696150
Health Authority:	United Kingdom: Department of Health

Keywords provided by NHS Greater Glasgow and Clyde:

ultrasound
hip
pain

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 15, 2009