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Minimum Effective Volume for Selective Trunk Block

NCT04773405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-11-18

No results posted yet for this study

Summary

The objective of this study is to identify the minimum effective dosage of a mixture of two local anaesthetic drugs called 'levobupivacaine' and 'lignocaine with epinephrine" used to produce an effective ultrasound guided selective trunk block for surgical anaesthesia of the upper limb.

Conditions

  • Musculoskeletal Diseases or Conditions

Interventions

DRUG

a 1: 1 mixture of 2% lidocaine with 5ug/ml epinephrine and 0.5% levobupivacaine

This study adopts a "Modified Narayana rule (MNR)", a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELAV90) of cases of the aforementioned local anaesthetic (LA) mixture, in order to produce the surgical anaesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries. Based on the principal investigator's clinical experience, the initial volume of 21ml will be used. Depending on the success or failure of the SeTB, which is defined as the readiness for surgery at 30 minutes after the block, the volume for the next patient will be adjusted up or down by 3ml (1ml for each trunk of brachial plexus located above the clavicle). The upper dose limit of the study to minimize the potential for local anaesthetic systemic toxicity will be 30ml and the lower dose limit will be 12ml, which will be of no clinical importance.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Manoj K Karmakar, MD · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2021-11-12
Completion
2021-11-17

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04773405 on ClinicalTrials.gov