Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block

Healthpoint Hospital

Status and phase: Unknown; Phase 4

Conditions: Orthopedic Procedures

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03613974

Healthpoint Hospital

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

lidocaine concentraion

Experimental group

Description:

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).

Treatment:

Drug: Lidocaine