Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block

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

Study Overview

• Status: Unknown
• Conditions: Orthopedic Procedures
• Intervention / Treatment: Drug: Lidocaine

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Drug: Lidocaine; patients will receive different lidocaine concentrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 min to 3 hour after the block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
motor block	degree of motor weakness	30 min after the block
motor recovery	complete recover of the motor power	3 hours till full recovery
analgesic duration	requesting painkiller	few hours after block

Collaborators and Investigators

• Sponsor: Healthpoint Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2018
• Primary Completion (Anticipated): March 15, 2019
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: foot and ankle; day case surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Healthpoint Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No