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?
2 other identifiers
interventional
269
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Jul 2008
Typical duration for phase_4 pain
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJune 12, 2008
June 1, 2008
2 years
June 9, 2008
June 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of patients with effective regional analgesia
Induction of anaesthesia
Secondary Outcomes (10)
hospital mortality
1months after operation
sensory function in lateral cutaneous nerve
0mins, 10mins 20mins post insertion of local anaesthetic
sensory function of femoral nerve
0mins, 10mins, 20mins after insertion of local anesthetic
sensory function of obturator nerve
0mins, 10mins, 20mins after insertion of local anesthetic
motor function of obturator nerve
0mins, 10mins and 20minutes after insrtion of local anesthetic
- +5 more secondary outcomes
Study Arms (3)
loss of resistance
PLACEBO COMPARATORAnterior psoas compartment nerve block inserted using loss of resistance
nerve stimulator
ACTIVE COMPARATORAnterior psoas compartment nerve block inserted using nerve stimulator
ultrasound
ACTIVE COMPARATORAnterior psoas compartment nerve block inserted using ultrasound
Interventions
Use of ultrasound to guide the insertion of anterior psoas compartment block
The use of the nerve stimulator to guide insertion of the anterior psoas compartment block
Use of ultrasound to guide the insertion of anterior psoas compartment block
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- Golden Jubilee National Hospitalcollaborator
Study Sites (4)
Gartnavel General hospital
Glasgow, Lanarkshire, G12 0YN, United Kingdom
Glasgow Royal Infrimary
Glasgow, Lanarkshire, G4, United Kingdom
Golden Jubilee hospital
Glasgow, Lanarkshire, United Kingdom
Royal alexandra hospital
Paisley, Renfrewshire, PA2, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Malcolm watson, MB ChB FRCA
NHS Greater Glasgow and Clyde
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 12, 2008
Study Start
July 1, 2008
Primary Completion
July 1, 2010
Study Completion
August 1, 2010
Last Updated
June 12, 2008
Record last verified: 2008-06