Femoral Neck FracturesPhase 4NCT00926666
A Dose Finding Study for Pain Relief of a Broken Hip
A Phase 4 study testing Levobupivacaine in people with Femoral Neck Fractures, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 95 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Levobupivacaine
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Infirmary
Glasgow, Lanarkshire, G11 7AB
malcolm watson, Mb Ch B, 00442112069, malcolmwatson.wtson@ntlworld.com
Emily Walker, MM ChB
About this study
Official title: A Dose Finding Study for Ultrasound Guided Anterior Psoas Compartment Blocks in Patients With a Fractured Neck of Femur?
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.
Read more
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.
- Conditions
- Femoral Neck Fractures
- Being tested
- Levobupivacaine
- Keywords
- Ageing, Pain, Pharmacology, Imaging, Anaesthesiology, Musculoskeletal disease
- Medical subject headings
- Femoral Neck Fractures, Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Measured: 24 hours after local anaesthetic nerve block
Secondary outcomes (5)
VAS resting acute pain scores
Measured: 10 mins, 20 mins and 30 mins after nerve block
Blood pressure, respiratory rate, pulse and oxygen saturations
Measured: 10 mins, 20 mins and 30 mins after nerve block
Liver function tests
Measured: Before nerve block
Venous blood gases
Measured: before nerve block
Serum levels of levobupivacaine
Measured: At 5, 10, 20, 30 and 60 mins after nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Investigators
- Malcolm J Watson, MB chB, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926666
- Sponsor's protocol ID
- MW001
- Other IDs
- EURACT 2009-013462-25, R+D:NumberGN09AN334
- Status last verified
- Aug 2009
- First submitted
- 22 Jun 2009
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study for Ultrasound Guided Anterior Psoas Compartment Blocks in Patients With a Fractured Neck of Femur?
- ClinicalTrials.gov ID
- NCT00926666
- Acronym / sponsor ID
- MW001
- Conditions
- Femoral Neck Fractures
- Keywords
- Ageing, Pain, Pharmacology, Imaging, Anaesthesiology, Musculoskeletal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 35 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineDose 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. | Drug | – |
Primary outcome
Duration of analgesia
Time frame: 24 hours after local anaesthetic nerve block
5 secondary outcomes
VAS resting acute pain scores
Time frame: 10 mins, 20 mins and 30 mins after nerve block
Blood pressure, respiratory rate, pulse and oxygen saturations
Time frame: 10 mins, 20 mins and 30 mins after nerve block
Liver function tests
Time frame: Before nerve block
Venous blood gases
Time frame: before nerve block
Serum levels of levobupivacaine
Time frame: At 5, 10, 20, 30 and 60 mins after nerve block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm J Watson, MB chB principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine in people with Femoral Neck Fractures, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: 24 hours after local anaesthetic nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.