Orthopedic ProceduresPhase 4NCT03613974
Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block
A Phase 4 study testing Lidocaine in people with Orthopedic Procedures, run by Healthpoint Hospital.
Trial summary
using a biased-coin design up-down sequential method, different concentration of lidocaine will be used for popliteal block After 45 successful block (positive response), the data will be used to calculate the minimum lidocaine concentration that can result in successful popliteal block in 90% of patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Procedures
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2018to 31 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- orthopedic foot or ankle surgery
- day case surgery
Who cannot join
- <18y,
- ASA class greater >III,
- obese (BMI >30),
- patients with low body weight, who required lidocaine dose is of more than 4.5mg.kg-1
- peripheral neuropathy,
- motor weakness,
- infection at the injection site
- any contraindications for medications in the study.
About this study
Official title: Successful Popliteal Block Using Lidocaine; What is the Minimum Effective Anesthesia Concentration (MEAC90)
using a biased-coin design up-down sequential method, different concentration of lidocaine will be used for popliteal block After 45 successful block (positive response), the data will be used to calculate the minimum lidocaine concentration that can result in successful popliteal block in 90% of patients
Read the detailed description
The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response, the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response, the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11).
- Conditions
- Orthopedic Procedures
- Being tested
- Lidocaine
- Keywords
- foot and ankle, day case surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
patients will receive different lidocaine concentrations
| Study group | Role | What they receive |
|---|---|---|
| lidocaine concentraion | Experimental | the popliteal block will be performed (once) in all patients using 20 ml of lidoacine. The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response (failed block), the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response (successful block), the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11). Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful popliteal block (positive response)
Sensory block will be assessed using pinprick sensation. Complete sensory block = unable to recognize pinprick sensation. Intra-operative pain will be assessed using Visual Analogue Scale (VAS) 0 = No pain, 10 = Worst imaginable pain.
Successful block = complete sensory block + pain free surgery (VAS = 0).
Measured: 30 min to 3 hour after the block
Secondary outcomes (3)
motor block
degree of motor weakness
Measured: 30 min after the block
motor recovery
complete recover of the motor power
Measured: 3 hours till full recovery
analgesic duration
requesting painkiller
Measured: few hours after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start15 Dec 2018 (estimated)
- Primary completion15 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic ProceduresStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthpoint Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Muhammad Taha, Healthpoint Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613974
- Sponsor's protocol ID
- Healthpoint Hospital
- Status last verified
- Nov 2018
- First submitted
- 20 Jul 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Popliteal Block Using Lidocaine; What is the Minimum Effective Anesthesia Concentration (MEAC90)
- ClinicalTrials.gov ID
- NCT03613974
- Acronym / sponsor ID
- Healthpoint Hospital
- Conditions
- Orthopedic Procedures
- Keywords
- foot and ankle, day case surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Healthpoint HospitalUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 15 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 3 Aug 2018 (actual)
- 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.
using a biased-coin design up-down sequential method, different concentration of lidocaine will be used for popliteal block After 45 successful block (positive response), the data will be used to calculate the minimum lidocaine concentration that can result in successful popliteal block in 90% of patients
Detailed description
The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response, the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response, the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lidocaine concentraion | Experimental | Drug: Lidocainethe popliteal block will be performed (once) in all patients using 20 ml of lidoacine. The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response (failed block), the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response (successful block), the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- orthopedic foot or ankle surgery
- day case surgery
Key exclusion criteria (8 listed)
- <18y,
- ASA class greater >III,
- obese (BMI >30),
- patients with low body weight, who required lidocaine dose is of more than 4.5mg.kg-1
- peripheral neuropathy,
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 |
|---|---|---|
| Lidocainepatients will receive different lidocaine concentrations | Drug | lidocaine concentraion |
Primary outcome
successful popliteal block (positive response)
Time frame: 30 min to 3 hour after the block
Sensory block will be assessed using pinprick sensation. Complete sensory block = unable to recognize pinprick sensation. Intra-operative pain will be assessed using Visual Analogue Scale (VAS) 0 = No pain, 10 = Worst imaginable pain. Successful block = complete sensory block + pain free surgery (VAS = 0).
3 secondary outcomes
motor block
Time frame: 30 min after the block
motor recovery
Time frame: 3 hours till full recovery
analgesic duration
Time frame: few hours after block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Orthopedic Procedures, run by Healthpoint Hospital.
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 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
successful popliteal block (positive response) (time frame: 30 min to 3 hour after the 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 14 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.