Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block

Orthopedic Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03613974
• Other study ID #: Healthpoint Hospital
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 15, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: November 2018
• Source: Healthpoint Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Orthopedic Procedures

Intervention

Drug:
• Lidocaine
patients will receive different lidocaine concentrations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	motor block	degree of motor weakness	30 min after the block
Secondary	motor recovery	complete recover of the motor power	3 hours till full recovery
Secondary	analgesic duration	requesting painkiller	few hours after block