NCT04773405

Minimum Effective Volume for Selective Trunk Block

Minimum Effective Local Anaesthetic Volume of a 1:1 Mixture of 2% Lidocaine With 5ug/ml of Epinephrine and 0.5% Levobupivacaine Required for Ultrasound Guided Selective Trunk Block: A Dose Finding Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ultrasound is widely used for brachial plexus block (BPB) and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks. Since majority of the innervation to the upper extremity, including the shoulder, arises from the three trunks (superior, middle and inferior) of the brachial plexus, so targeted injections of the individual trunks of the brachial plexus under ultrasound guidance will produce surgical anaesthesia of the entire upper extremity (C5-T1). Principal Investigator refers to this novel technique "selective trunk block" (SeTB) and the preliminary experience with SeTB for surgical anaesthesia of the entire upper extremity has been very encouraging. Currently there are no data describing an optimal dose or volume of local anaesthetic for SeTB. The aim of this study is to identify the minimum dosage of 1:1 mixture of 'levobupivacaine' and "lignocaine with epinephrine" required to produce effective surgical anaesthesia in at least 90% of patients presented for upper limb surgery.

Conditions

• Musculoskeletal Diseases or Conditions

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-10
• Primary completion: 2021-11-12
• Completion: 2021-11-17
• First posted: 2021-02-26
• Last updated: 2021-11-18

Locations

1 site across 1 country: Hong Kong