Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block

NCT ID: NCT03613974

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2019-03-31

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).

Conditions

Orthopedic Procedures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lidocaine concentraion

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).

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

patients will receive different lidocaine concentrations

Interventions

Lidocaine

patients will receive different lidocaine concentrations

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• orthopedic foot or ankle surgery
• day case surgery

Exclusion Criteria

• <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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Muhammad Taha

Consultant of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Healthpoint Hospital

Identifier Type: -

Identifier Source: org_study_id