PainPhase 4NCT00696150
Can the Femoral Nerve Block be Improved by Ultrasound Guidance?
A Phase 4 study testing determination of method with highest efficacy (ultrasound or nerve stimulator), nerve stimulator and loss of resistance in people with Pain, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- determination of method with highest efficacy (ultrasound or nerve stimulator), nerve stimulator and loss of resistance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2008to Aug 2010
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Gartnavel General hospital
Glasgow, Lanarkshire, G12 0YN
Graham Hilditch, MB chB, FRCA
Glasgow Royal Infrimary
Glasgow, Lanarkshire, G4
Colin Rae, Mb chB, FRCA
Golden Jubilee hospital
Glasgow, Lanarkshire
Micheal Higgins, MB chB, FRCA
Royal alexandra hospital
Paisley, Renfrewshire, PA2
Paul Allcock, Mb ChB, FRCS
About this study
Official title: 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?
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.
- Conditions
- Pain
- Being tested
- determination of method with highest efficacy (ultrasound or nerve stimulator), nerve stimulator, loss of resistance
- Keywords
- ultrasound, hip, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determination of method with highest efficacy (ultrasound or nerve stimulator)Procedure or surgery
Use of ultrasound to guide the insertion of anterior psoas compartment block
nerve stimulatorProcedure or surgery
The use of the nerve stimulator to guide insertion of the anterior psoas compartment block
loss of resistanceProcedure or surgery
Use of ultrasound to guide the insertion of anterior psoas compartment block
| Study group | Role | What they receive |
|---|---|---|
| loss of resistance | Placebo comparator | Anterior psoas compartment nerve block inserted using loss of resistance Receives: Procedure: loss of resistance |
| nerve stimulator | Active comparator | Anterior psoas compartment nerve block inserted using nerve stimulator Receives: Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator); Procedure: nerve stimulator |
| ultrasound | Active comparator | Anterior psoas compartment nerve block inserted using ultrasound Receives: Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with effective regional analgesia
Measured: Induction of anaesthesia
Secondary outcomes (10)
hospital mortality
Measured: 1months after operation
sensory function in lateral cutaneous nerve
Measured: 0mins, 10mins 20mins post insertion of local anaesthetic
sensory function of femoral nerve
Measured: 0mins, 10mins, 20mins after insertion of local anesthetic
sensory function of obturator nerve
Measured: 0mins, 10mins, 20mins after insertion of local anesthetic
motor function of obturator nerve
Measured: 0mins, 10mins and 20minutes after insrtion of local anesthetic
motor function of femoral nerve
Measured: 0mins,10mins and 20mins post insertion of local anesthetic
acute mental test scores
Measured: 6hours and 24 hours post operatively
total morphine dose administered
Measured: 6hours and 24 hours post operstively
day first mobilise post operatively
Measured: post operatively 0-10 days
patient satisfaction scores
Measured: 6 hours and 24hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Investigators
- Malcolm watson, MB ChB FRCA, Study chair, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696150
- Sponsor's protocol ID
- ultrasound for hip # study-1
- Other IDs
- CSO reference CAF/07/05
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 12 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT00696150
- Acronym / sponsor ID
- ultrasound for hip # study-1
- Conditions
- Pain
- Keywords
- ultrasound, hip, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 12 Jun 2008 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| loss of resistance | Placebo comparator | Procedure: loss of resistanceAnterior psoas compartment nerve block inserted using loss of resistance |
| nerve stimulator | Active comparator | Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator), Procedure: nerve stimulatorAnterior psoas compartment nerve block inserted using nerve stimulator |
| ultrasound | Active comparator | Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)Anterior psoas compartment nerve block inserted using ultrasound |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| determination of method with highest efficacy (ultrasound or nerve stimulator)Use of ultrasound to guide the insertion of anterior psoas compartment block | Procedure or surgery | nerve stimulator, ultrasound |
| nerve stimulatorThe use of the nerve stimulator to guide insertion of the anterior psoas compartment block | Procedure or surgery | nerve stimulator |
| loss of resistanceUse of ultrasound to guide the insertion of anterior psoas compartment block | Procedure or surgery | loss of resistance |
Primary outcome
percentage of patients with effective regional analgesia
Time frame: Induction of anaesthesia
10 secondary outcomes
hospital mortality
Time frame: 1months after operation
sensory function in lateral cutaneous nerve
Time frame: 0mins, 10mins 20mins post insertion of local anaesthetic
sensory function of femoral nerve
Time frame: 0mins, 10mins, 20mins after insertion of local anesthetic
sensory function of obturator nerve
Time frame: 0mins, 10mins, 20mins after insertion of local anesthetic
motor function of obturator nerve
Time frame: 0mins, 10mins and 20minutes after insrtion of local anesthetic
motor function of femoral nerve
Time frame: 0mins,10mins and 20mins post insertion of local anesthetic
acute mental test scores
Time frame: 6hours and 24 hours post operatively
total morphine dose administered
Time frame: 6hours and 24 hours post operstively
day first mobilise post operatively
Time frame: post operatively 0-10 days
patient satisfaction scores
Time frame: 6 hours and 24hours post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2008.
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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 watson, MB ChB FRCA study chair
NHS Greater Glasgow and Clyde
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing determination of method with highest efficacy (ultrasound or nerve stimulator), nerve stimulator and loss of resistance in people with Pain, run by NHS Greater Glasgow and Clyde at 4 sites 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 4 inclusion and 6 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 12 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
Contact Malcolm Watson, MBChB, MRCP, FRCA (01412116291, mwatson@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with effective regional analgesia (time frame: Induction of anaesthesia). 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 12 Jun 2008; AzTrials last refreshed its copy on 8 Nov 2026.