Bimalleolar Fractures of the Ankle.Phase 4NCT01759524
To Compare lidocaine2%/Clonidine in Combination, With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade
A Phase 4 study testing Bupivacaine and Lidocaine in people with Bimalleolar Fractures of the Ankle. and Sciatic Nerve Block., run by Cork University Hospital at 1 site in Ireland.
Trial summary
Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone produces analgesia. When administered centrally its effects are predominantly due to its alpha 2 activity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bimalleolar Fractures of the Ankle., Sciatic Nerve Block., Saphenous Nerve Block.
- What is being tested?
- Bupivacaine and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2011to Jan 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3 patients scheduled to undergo semi elective ankle/foot surgery with regional anaesthesia will be recruited.
Who cannot join
- patient refusal,
- allergy to local anaesthetics,
- coagulopathy,
- malignancy or infection at the block performance site,
- significant peripheral neuropathy or neurologic disorder of the lower extremity or any other contraindication to sciatic and saphenous nerve block,
- pregnancy,
- history of alcohol or drug dependency/abuse (defined as >40 IU/week),
- a history of significant cognitive or psychiatric disorder that may affect patient assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare lidocaine2%/Clonidine in Combination With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade
Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone produces analgesia. When administered centrally its effects are predominantly due to its alpha 2 activity. When administered peripherally it prolongs the analgesia through its vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another possibility is that it prolongs analgesia of peripheral nerve blocks due to a hyperpolarisation current .Clonidine has been used successfully both for upper and lower limb blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A major concern with the lower limb blocks is the risk of falls associated with prolonged motor blockade during early mobilisation. Clonidine has been shown to intensify and prolong the motor blockade produced by long acting local anaesthetics. Lidocaine when used in combination with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses of clonidine are associated with longer analgesia but with more side effects. Clonidine in a dose of 90 mcg administered with local anaesthetics can produce analgesia for up to 10 hrs with minimal side effects. The aim of this study is to compare lidocaine 2% + clonidine 1.5mcg/kg with bupivacaine alone in terms of block selectivity for combined sciatic -saphenous nerve block in patients under going semi elective foot/ankle procedures.
- Conditions
- Bimalleolar Fractures of the Ankle., Sciatic Nerve Block., Saphenous Nerve Block., Post Operative Analgesia Duration.
- Being tested
- Bupivacaine, Lidocaine
- Keywords
- local anaesthesia, analgesia, bupivacaine, lidocaine, clonidine, sciatic nerve, saphenous nerve
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called 0.5% bupivacaine, marcaine.
LidocaineDrug
Also called 2% lidocaine + 1.5 mcg/kg clonidine
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | 40 mls of 2% lidocaine + 1.5 mcg/kg will be drawn up by an attending anaesthetist to blind the operator. Patients in this group will receive an ultra sound guided sciatic nerve block , 3 cm proximal to the nerve bifurcation, with 25 mls of the above mentioned solution and an ultra sound guided saphenous nerve block in the midthigh just lateral to the profunda femoris artery with 15 mls of the above mentioned solution. Receives: Drug: Lidocaine |
| Group B | Active comparator | 40 mls of 0.5% bupivacaine will be drawn up by an attending anaesthetist to blind the operator. Patients in this group will receive an ultra sound guided sciatic nerve block , 3 cm proximal to the nerve bifurcation, with 25 mls of the above mentioned solution and an ultra sound guided saphenous nerve block in the midthigh just lateral to the profunda femoris artery with 15 mls of the above mentioned solution. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative sensory and motor block.
Postoperative analgesia/duration of block will be assessed at 4,6 8, 10,12,16 hrs or until complete recovery of sensation to cold spray upto 36 hours.
Measured: 36 hours.
Secondary outcomes (1)
Onset time of block.
After completion of the two blocks the effect will be assessed every 5 minutes for onset time defined as the time from withdrawal of needle (t0) to complete loss of sensation in the sensory dermatomes of both sciatic and saphenous nerve.
The sensory level will be assessed on toes and forefoot due to post operative cast restricted access to full tibial and peroneal nerve dermatomes.
Motor block assessment will carried out using bromage and modified bromage scale for tibial and peroneal nerve
Measured: every 5 minutes upto 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startOct 2011
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bimalleolar Fractures of the Ankle.Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. Jassim Rauf, Cork University Hospital
- Investigators
- George Shorten, FCARCSI PhD, Study chair, Cork University Hospital, Cork, Ireland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759524
- Sponsor's protocol ID
- JR-786-GS
- Status last verified
- Nov 2013
- First submitted
- 27 Dec 2012
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare lidocaine2%/Clonidine in Combination With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade
- ClinicalTrials.gov ID
- NCT01759524
- Acronym / sponsor ID
- JR-786-GS
- Conditions
- Bimalleolar Fractures of the Ankle., Sciatic Nerve Block., Saphenous Nerve Block., Post Operative Analgesia Duration.
- Keywords
- local anaesthesia, analgesia, bupivacaine, lidocaine, clonidine, sciatic nerve, saphenous nerve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- First posted
- 3 Jan 2013 (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.
Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone produces analgesia. When administered centrally its effects are predominantly due to its alpha 2 activity. When administered peripherally it prolongs the analgesia through its vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another possibility is that it prolongs analgesia of peripheral nerve blocks due to a hyperpolarisation current .Clonidine has been used successfully both for upper and lower limb blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A major concern with the lower limb blocks is the risk of falls associated with prolonged motor blockade during early mobilisation. Clonidine has been shown to intensify and prolong the motor blockade produced by long acting local anaesthetics. Lidocaine when used in combination with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses of clonidine are associated with longer analgesia but with more side effects. Clonidine in a dose of 90 mcg administered with local anaesthetics can produce analgesia for up to 10 hrs with minimal side effects. The aim of this study is to compare lidocaine 2% + clonidine 1.5mcg/kg with bupivacaine alone in terms of block selectivity for combined sciatic -saphenous nerve block in patients under going semi elective foot/ankle procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Drug: Lidocaine40 mls of 2% lidocaine + 1.5 mcg/kg will be drawn up by an attending anaesthetist to blind the operator. Patients in this group will receive an ultra sound guided sciatic nerve block , 3 cm proximal to the nerve bifurcation, with 25 mls of the above mentioned solution and an ultra sound guided saphenous nerve block in the midthigh just lateral to the profunda femoris artery with 15 mls of the above mentioned solution. |
| Group B | Active comparator | Drug: Bupivacaine40 mls of 0.5% bupivacaine will be drawn up by an attending anaesthetist to blind the operator. Patients in this group will receive an ultra sound guided sciatic nerve block , 3 cm proximal to the nerve bifurcation, with 25 mls of the above mentioned solution and an ultra sound guided saphenous nerve block in the midthigh just lateral to the profunda femoris artery with 15 mls of the above mentioned solution. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-3 patients scheduled to undergo semi elective ankle/foot surgery with regional anaesthesia will be recruited.
Key exclusion criteria (8 listed)
- patient refusal,
- allergy to local anaesthetics,
- coagulopathy,
- malignancy or infection at the block performance site,
- significant peripheral neuropathy or neurologic disorder of the lower extremity or any other contraindication to sciatic and saphenous nerve block,
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 |
|---|---|---|
| BupivacaineAlso: 0.5% bupivacaine, marcaine. | Drug | Group B |
| LidocaineAlso: 2% lidocaine + 1.5 mcg/kg clonidine | Drug | Group L |
Primary outcome
Duration of postoperative sensory and motor block.
Time frame: 36 hours.
Postoperative analgesia/duration of block will be assessed at 4,6 8, 10,12,16 hrs or until complete recovery of sensation to cold spray upto 36 hours.
1 secondary outcome
Onset time of block.
Time frame: every 5 minutes upto 40 minutes
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 19 Nov 2013.
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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.
George Shorten, FCARCSI PhD study chair
Cork University Hospital, Cork, Ireland.
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 Bupivacaine and Lidocaine in people with Bimalleolar Fractures of the Ankle. and Sciatic Nerve Block., 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 1 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: finished, as of the sponsor's last update on 19 Nov 2013. 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.
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?
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?
Duration of postoperative sensory and motor block. (time frame: 36 hours.). 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 19 Nov 2013.