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Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

Phase 4
Conditions
Pain
Interventions
Procedure: loss of resistance
Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)
Procedure: nerve stimulator
Registration Number
NCT00696150
Lead Sponsor
NHS Greater Glasgow and Clyde
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
269
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
loss of resistanceloss of resistanceAnterior psoas compartment nerve block inserted using loss of resistance
nerve stimulatordetermination of method with highest efficacy (ultrasound or nerve stimulator)Anterior psoas compartment nerve block inserted using nerve stimulator
nerve stimulatornerve stimulatorAnterior psoas compartment nerve block inserted using nerve stimulator
ultrasounddetermination of method with highest efficacy (ultrasound or nerve stimulator)Anterior psoas compartment nerve block inserted using ultrasound
Primary Outcome Measures
NameTimeMethod
percentage of patients with effective regional analgesiaInduction of anaesthesia
Secondary Outcome Measures
NameTimeMethod
acute mental test scores6hours and 24 hours post operatively
sensory function of femoral nerve0mins, 10mins, 20mins after insertion of local anesthetic
sensory function in lateral cutaneous nerve0mins, 10mins 20mins post insertion of local anaesthetic
sensory function of obturator nerve0mins, 10mins, 20mins after insertion of local anesthetic
motor function of obturator nerve0mins, 10mins and 20minutes after insrtion of local anesthetic
day first mobilise post operativelypost operatively 0-10 days
patient satisfaction scores6 hours and 24hours post operatively
hospital mortality1months after operation
total morphine dose administered6hours and 24 hours post operstively
motor function of femoral nerve0mins,10mins and 20mins post insertion of local anesthetic

Trial Locations

Locations (4)

Gartnavel General hospital

🇬🇧

Glasgow, Lanarkshire, United Kingdom

Royal alexandra hospital

🇬🇧

Paisley, Renfrewshire, United Kingdom

Glasgow Royal Infrimary

🇬🇧

Glasgow, Lanarkshire, United Kingdom

Golden Jubilee hospital

🇬🇧

Glasgow, Lanarkshire, United Kingdom

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