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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03613974
Other study ID # Healthpoint Hospital
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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