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A Dose Finding Study for Pain Relief of a Broken Hip

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926666
Recruitment Status : Unknown
Verified August 2009 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2009
Last Update Posted : August 4, 2009
Chief Scientist Office of the Scottish Government
Information provided by:
NHS Greater Glasgow and Clyde

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 allow visualization of all the anatomical structures and the distribution of the local anesthetic on injection. The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a fractured hip is 14.3% (Bottle and Aylin 947-51).

The aim of this clinical trial is to determine the effective dose of local anesthetic to provide pain relief to patients with a broken hip using ultrasound to guide needle insertion. The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a fractured hip was 14.3%. Patients for emergency surgical fixation or replacement of broken hip will be recruited prior to surgical fixation. All patients recruited to this study will receive standard anesthesia and surgical fixation of their broken hip.

The trial can be divided into two sequential parts; the results of part A will be an amount of local anesthetic which will relieve pain of a broken hip in 95% of all patients. Part B will determine the duration of pain relief provided by the amount of local anaesthetic from part A and blood levels of local anesthetic.

In parts A and B a standard pain relieving nerve block to numb the nerves supplying the hip joint will be administered using ultrasound to guide the injection of local anesthetic. The patient will then be observed for 30 minutes during which time the feeling in the upper leg and pain scores will be recorded. Patients with ineffective nerve blocks will be given immediate pain relief and withdrawn from further participation in the study.

In part A the amount of local anesthetic for the next patient will be increased or decreased if the nerve block is ineffective or effective respectively.

In part B the dose will be the same (calculated from the results of part A). In order to determine the duration of pain relief pain scores will be recorded hourly for up to 24 hours. Blood samples will be taken before the pain relieving nerve block and at 5, 10, 20, 30 and 60 minutes afterwards.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Drug: Levobupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: A Dose Finding Study for Ultrasound Guided Anterior Psoas Compartment Blocks in Patients With a Fractured Neck of Femur?
Study Start Date : October 2009
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Levobupivacaine
    Dose finding study for levobupivacaine in fractured neck of femur patients. Ultrasound guided anterior psoas compartment nerve block to determine EC50 using up/Down methodology in patient before surgery to fix broken hip.

Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 24 hours after local anaesthetic nerve block ]

Secondary Outcome Measures :
  1. VAS resting acute pain scores [ Time Frame: 10 mins, 20 mins and 30 mins after nerve block ]
  2. Blood pressure, respiratory rate, pulse and oxygen saturations [ Time Frame: 10 mins, 20 mins and 30 mins after nerve block ]
  3. Liver function tests [ Time Frame: Before nerve block ]
  4. Venous blood gases [ Time Frame: before nerve block ]
  5. Serum levels of levobupivacaine [ Time Frame: At 5, 10, 20, 30 and 60 mins after nerve block ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926666

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United Kingdom
Western Infirmary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G11 7AB
Contact: malcolm watson, Mb Ch B    00442112069   
Sub-Investigator: Emily Walker, MM ChB         
Principal Investigator: Alexander Binning, MB chB         
Sub-Investigator: Simone Rowell, Mb ChB         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
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Principal Investigator: Malcolm J Watson, MB chB NHS Greater Glasgow and Clyde

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Responsible Party: Dr aureen Travers / R+D Cooridator, NHS Greater Glasgow and Clyde Identifier: NCT00926666     History of Changes
Other Study ID Numbers: MW001
EURACT 2009-013462-25
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009
Keywords provided by NHS Greater Glasgow and Clyde:
Musculoskeletal disease
Additional relevant MeSH terms:
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Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents