Fractured Neck of FemurNCT01527812
Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery
A study testing Femoral nerve block in people with Fractured Neck of Femur, run by Cork University Hospital at 1 site in Ireland.
Trial summary
The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Fractured Neck of Femur
- What is being tested?
- Femoral nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Dec 2009to Feb 2012
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fractured neck of femur surgical fixation performed under spinal anaesthesia
- ASA I to III
Who cannot join
- Patient refusal
- Coagulation disorders
- Head injury or other associated injuries
- Previous vascular surgery in the femoral area.
- Loss of consciousness and signs of acute coronary syndrome
- Mini-Mental Score < 25 (see appendix 3)
Show all 9Show fewer
- Allergy to lignocaine,
- Skin lesions/infection at site of injection
- Sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Operative Fixation of Fractured Neck of Femur
The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.
Read the detailed description
Fractured neck of femur is a common cause of admission to hospital in elderly patients and requires operative fixation. The recommended anaesthetic technique for these cases is spinal anaesthesia, which is performed with the patient in lateral decubitus. Positioning the patient prior to administering spinal anaesthesia is the most painful manouvre due to the movement of the fractured bone.
Regional anaesthesia is effective in alleviating pain due to trauma, and it has the advantage of producing localized but complete pain relief (1). Femoral nerve blockade prior to positioning for spinal anaesthesia provides excellent pain relief and is a well tolerated procedure (2-5).
Using ultrasound guided femoral nerve block is a relative new method to improving the block success rate. It is widely used in our hospital. In a recent study Casati and al. showed a 42 % decrease of ED50% using ultrasound for localization of the femoral nerve (6). In a recent editorial by Brian D. Sites was mentioned that the positioning of the local anaesthetic in ultrasound guided blocks is unclear (7). We currently follow different patterns in relation to injection of the local anaesthetic solution around the femoral nerve. One of them is a circumferencial spread around the nerve. This, however, needs several needle passes which are likely to be painful for the patient. Another option is injecting the local anaesthetic on one side, above or below the nerve without changing the position of the tip of the needle, avoiding patient discomfort. Whether this results in a comparable quality of sensory block is unknown. The femoral nerve is separated in branches at this level and we assume that the spread of local anaesthetic may influence the quality and the distribution of the block. We propose to study the characteristics of femoral nerve block in relation to different patterns of local anaesthetic injection (circumferencial, inferior or superior).
- Conditions
- Fractured Neck of Femur
- Being tested
- Femoral nerve block
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Above the femoral nerve | Experimental | In Group I we will inject the local anaesthetic below the fascia iliaca and above the femoral nerve. Receives: Procedure: Femoral nerve block |
| Below the femoral nerve | Experimental | In Group II we will inject the local anaesthetic below the femoral nerve and above the fascia of the iliopsoas muscle. Receives: Procedure: Femoral nerve block |
| Circumferential | Experimental | In Group III a circumferential spread will be achieved with multiple injections. Receives: Procedure: Femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia.
Independent blinded observer will assess the patient in the first 30 minutes, in every 5 minute. Sensory perception will be assess by using cold spray in the area of the terminal branch of femoral nerve.
We will assess the pain on passive movement of the limb (elevating 30 degree) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the patient will be positioned for spinal anaesthesia.
If the threshold isn't achieved by 30 minutes, the block will be classified as failure. Additional opioid medication and/or sedation will be administered.
Measured: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.
Secondary outcomes (4)
Sensory distribution of the nerve block.
An independent blinded observer (not present during block placement) will assess in the first 30 minutes (at 5 minute intervales) the sensory nerve block using a modified Bromage score. Sensory perception will be assessed using cold (ethyl chloride spray) in the area of the vastus medialis, vastus intermedius, vastus lateralis and saphenous nerve innervation area (terminal branch of femoral nerve).
Measured: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.
Number of needle passes
The Anaesthestist who performing the femoral nerve block was asked how many needle passes needed for the femoral nerve block.
Measured: during performing the femoral nerve block
Femoral nerve block onset time
We will assess the pain on passive movement of the limb (elevating 30 degree from the initial positioning) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the sensory block will be deemed adequate and the patient will be positioned on the side for spinal anaesthesia.
Measured: In the first 30 minutes after the femoral nerve block
Patient satisfaction
After the surgery during the recovery time, we will ask the patients regarding there Satisfaction, will be used visual analog scale 0-100 mm for measurement.
Measured: After the surgery in the recovery area before the patient will be discharged to the ward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fractured Neck of FemurStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szilard Szucs, Cork University Hospital
- Investigators
- Szilard Szucs, MD, Principal investigator, Cork University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527812
- Sponsor's protocol ID
- ECM 4 (zz) 08/12/09
- Other IDs
- ECM 4 (zz) 08/12/09
- Status last verified
- Feb 2012
- First submitted
- 1 Feb 2012
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Szucs S, Morau D, Sultan SF, Iohom G, Shorten G. A comparison of three techniques (local anesthetic deposited circumferential to vs. above vs. below the nerve) for ultrasound guided femoral nerve block. BMC Anesthesiol. 2014 Jan 25;14:6. doi: 10.1186/1471-2253-14-6.
PubMed 24460975
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Operative Fixation of Fractured Neck of Femur
- ClinicalTrials.gov ID
- NCT01527812
- Acronym / sponsor ID
- ECM 4 (zz) 08/12/09
- Conditions
- Fractured Neck of Femur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Feb 2012 (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.
The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.
Detailed description
Fractured neck of femur is a common cause of admission to hospital in elderly patients and requires operative fixation. The recommended anaesthetic technique for these cases is spinal anaesthesia, which is performed with the patient in lateral decubitus. Positioning the patient prior to administering spinal anaesthesia is the most painful manouvre due to the movement of the fractured bone.
Regional anaesthesia is effective in alleviating pain due to trauma, and it has the advantage of producing localized but complete pain relief (1). Femoral nerve blockade prior to positioning for spinal anaesthesia provides excellent pain relief and is a well tolerated procedure (2-5).
Using ultrasound guided femoral nerve block is a relative new method to improving the block success rate. It is widely used in our hospital. In a recent study Casati and al. showed a 42 % decrease of ED50% using ultrasound for localization of the femoral nerve (6). In a recent editorial by Brian D. Sites was mentioned that the positioning of the local anaesthetic in ultrasound guided blocks is unclear (7). We currently follow different patterns in relation to injection of the local anaesthetic solution around the femoral nerve. One of them is a circumferencial spread around the nerve. This, however, needs several needle passes which are likely to be painful for the patient. Another option is injecting the local anaesthetic on one side, above or below the nerve without changing the position of the tip of the needle, avoiding patient discomfort. Whether this results in a comparable quality of sensory block is unknown. The femoral nerve is separated in branches at this level and we assume that the spread of local anaesthetic may influence the quality and the distribution of the block. We propose to study the characteristics of femoral nerve block in relation to different patterns of local anaesthetic injection (circumferencial, inferior or superior).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Above the femoral nerve | Experimental | Procedure: Femoral nerve blockIn Group I we will inject the local anaesthetic below the fascia iliaca and above the femoral nerve. |
| Below the femoral nerve | Experimental | Procedure: Femoral nerve blockIn Group II we will inject the local anaesthetic below the femoral nerve and above the fascia of the iliopsoas muscle. |
| Circumferential | Experimental | Procedure: Femoral nerve blockIn Group III a circumferential spread will be achieved with multiple injections. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fractured neck of femur surgical fixation performed under spinal anaesthesia
- ASA I to III
Key exclusion criteria (9 listed)
- Patient refusal
- Coagulation disorders
- Head injury or other associated injuries
- Previous vascular surgery in the femoral area.
- Loss of consciousness and signs of acute coronary syndrome
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 |
|---|---|---|
| Femoral nerve blockWe will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected. | Procedure or surgery | Above the femoral nerve, Below the femoral nerve, Circumferential |
Primary outcome
Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia.
Time frame: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.
Independent blinded observer will assess the patient in the first 30 minutes, in every 5 minute. Sensory perception will be assess by using cold spray in the area of the terminal branch of femoral nerve. We will assess the pain on passive movement of the limb (elevating 30 degree) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the patient will be positioned for spinal anaesthesia. If the threshold isn't achieved by 30 minutes, the block will be classified as failure. Additional opioid medication and/or sedation will be administered.
4 secondary outcomes
Sensory distribution of the nerve block.
Time frame: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.
Number of needle passes
Time frame: during performing the femoral nerve block
Femoral nerve block onset time
Time frame: In the first 30 minutes after the femoral nerve block
Patient satisfaction
Time frame: After the surgery in the recovery area before the patient will be discharged to the ward.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
- Derived from this study: PubMed 24460975Szucs S, Morau D, Sultan SF, Iohom G, Shorten G. A comparison of three techniques (local anesthetic deposited circumferential to vs. above vs. below the nerve) for ultrasound guided femoral nerve block. BMC Anesthesiol. 2014 Jan 25;14:6. doi: 10.1186/1471-2253-14-6.
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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.
Szilard Szucs, MD principal investigator
Cork University Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve block in people with Fractured Neck of Femur, run by Cork University Hospital at 1 site in Ireland.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 3 Apr 2012. 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 Ireland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia. (time frame: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01527812, which also lists 1 linked publication.
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 3 Apr 2012.