Clinical trial NCT00696150: Can the Femoral Nerve Block be Improved by Ultrasound Guidance?
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: ultrasound
hip
pain
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Golden Jubilee National Hospital
First posted: 2008-06-12
Enrollment: 269
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: percentage of patients with effective regional analgesia
timeFrame: Induction of anaesthesia
Secondary outcomes:
measure: hospital mortality
timeFrame: 1months after operation
measure: sensory function in lateral cutaneous nerve
timeFrame: 0mins, 10mins 20mins post insertion of local anaesthetic
measure: sensory function of femoral nerve
timeFrame: 0mins, 10mins, 20mins after insertion of local anesthetic
measure: sensory function of obturator nerve
timeFrame: 0mins, 10mins, 20mins after insertion of local anesthetic
measure: motor function of obturator nerve
timeFrame: 0mins, 10mins and 20minutes after insrtion of local anesthetic
measure: motor function of femoral nerve
timeFrame: 0mins,10mins and 20mins post insertion of local anesthetic
measure: acute mental test scores
timeFrame: 6hours and 24 hours post operatively
measure: total morphine dose administered
timeFrame: 6hours and 24 hours post operstively
measure: day first mobilise post operatively
timeFrame: post operatively 0-10 days
measure: patient satisfaction scores
timeFrame: 6 hours and 24hours post operatively
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Gartnavel General hospital
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infrimary
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Golden Jubilee hospital
state: Lanarkshire
city: Paisley
country: United Kingdom
facility: Royal alexandra hospital
state: Renfrewshire
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Malcolm watson, MB ChB FRCA
role: STUDY_CHAIR
References: