Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block

NCT03613974 | Unknown Phase 4 DMC

• 1 other identifier: Healthpoint Hospital
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Orthopedic Procedures

Keywords

foot and ankle; day case surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• motor block

  30 min after the block

• motor recovery

  3 hours till full recovery

• analgesic duration

  few hours after block

Study Arms (1)

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).

Drug: Lidocaine

Interventions

Lidocaine DRUG

patients will receive different lidocaine concentrations

lidocaine concentraion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• orthopedic foot or ankle surgery
• day case surgery

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Healthpoint Hospital: lead

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: the patients and the assessment staff will not be aware with the given lidocaine concentration
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of anesthesia

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 3, 2018
• Study Start: December 15, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 31, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11