Status:

UNKNOWN

A Dose Finding Study for Pain Relief of a Broken Hip

Lead Sponsor:

NHS Greater Glasgow and Clyde

Collaborating Sponsors:

Chief Scientist Office of the Scottish Government

Conditions:

Femoral Neck Fractures

Eligibility:

All Genders

35-95 years

Phase:

PHASE4

Brief Summary

Studies have suggested a link with effective pain relief and reduced illness and death in high risk patients. Ultrasound guided nerve blocks have been associated with an increased success rate and all...

Eligibility Criteria

Inclusion

  • Emergency proximal fractured neck of femur for surgical fixation
  • Visual analogue pain score at rest of \>=5
  • American Society of Anaesthesiology grading \<=4
  • Able to give informed consent
  • Resting visual analogue pain score of greater than 50mm on a 100mm scale before recruitment
  • Patient is able to cooperate with sensory testing of lower limb function

Exclusion

  • Abnormal clotting screen (coagulopathy) or thrombocytopenia (\< 100,000)
  • Acute mental test score of \<=7 at any time preoperatively
  • Allergy to local anaesthetic
  • Contra-indication to levobupivacaine
  • Signs, symptoms or laboratory evidence of local infection or systemic sepsis
  • No pre-existing neurological deficit (sensory or motor) affecting the lower limb
  • Patient with lower limb amputations or other condition affecting sensation in lower limbs
  • Patient with a history of chronic pain

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2011

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT00926666

Start Date

October 1 2009

End Date

April 1 2011

Last Update

August 4 2009

Active Locations (1)

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1

Western Infirmary

Glasgow, Lanarkshire, United Kingdom, G11 7AB