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Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block

Successful Popliteal Block Using Lidocaine; What is the Minimum Effective Anesthesia Concentration (MEAC90)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03613974
Enrollment
50
Registered
2018-08-03
Start date
2018-12-15
Completion date
2019-03-31
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Procedures

Keywords

foot and ankle, day case surgery

Brief 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

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).

Interventions

DRUGLidocaine

patients will receive different lidocaine concentrations

Sponsors

Healthpoint Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

the patients and the assessment staff will not be aware with the given lidocaine concentration

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* orthopedic foot or ankle surgery * day case surgery

Exclusion criteria

patients * \<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.

Design outcomes

Primary

MeasureTime frameDescription
successful popliteal block (positive response)30 min to 3 hour after the blockSensory 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).

Secondary

MeasureTime frameDescription
motor block30 min after the blockdegree of motor weakness
motor recovery3 hours till full recoverycomplete recover of the motor power
analgesic durationfew hours after blockrequesting painkiller

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026