Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.5% levobupivacaine.
- Who it may be relevant to
- Registry conditions: Musculoskeletal Diseases or Conditions. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Minimum Effective Local Anesthetic Volume of 0.5% Levobupivacaine Required for Ultrasound Guided Superior Trunk Block for Shoulder Surgery
Overview
The objective of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.
Detailed description
Shoulder arthroscopic surgery is one of the most commonly performed procedures worldwide, and associated with significant postoperative pain. Currently, such surgery is performed either under general anaesthesia or under Interscalene brachial plexus block (ISBPB), which is a regional anaesthesia technique. However, ISBPB is associated with the highest incidence of hemi-diaphragmatic palsy of the operative side. Since majority of the innervation to the shoulder arises from or passes through the superior trunk of the brachial plexus, superior trunk block has been shown to have lesser impact on the phrenic nerve and it has been gaining popularity worldwide. Ultrasound is widely used for brachial plexus block 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 (superior, middle, and inferior trunks). However, there are no data describing an optimal volume of local anaesthetic for superior trunk block. The aim of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.
Interventions
- Drug 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% (MELVA90) of cases of the aforementioned local anesthetic (LA), in order to produce the surgical anesthesia of the patients scheduled for shoulder surgeries. Based on the principal investigator's clinical experience, the initial volume of 8ml will be used. Depending on the success or failure of the superior trunk block, which
Primary outcome measures
- Changes of sensory & motor blockade (Readiness for surgery) of the upper extremity [Time frame: within 45 minutes after the block at 5 minutes interval]
- Minimum effective volume (ml) of local anesthetic agent [Time frame: after nerve block till end of surgery]
Secondary outcome measures (8)
- Changes of motor blockade of the upper extremity [Time frame: within 45 minutes after the block at 5 minutes interval]
- Changes of sensory block of the upper extremity [Time frame: within 45 minutes after the block at 5 minutes interval]
- Percentage changes of the Diaphragmatic function [Time frame: Baseline (before block) and at 30 minutes after block]
- Changes of the Extensiveness of Diaphragmatic function [Time frame: calculated after block]
- Block performance time [Time frame: assess once before surgery]
- Discomfort score [Time frame: assess once before surgery]
- Paresthesia [Time frame: during the period of undergoing the nerve block]
- Complications [Time frame: during the nerve block till the end of surgery]
Eligibility criteria
Inclusion criteria
- American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper shoulder arthroscopic rotator cuff repair procedure
Exclusion criteria
- Patient refusal
- pregnancy
- skin infection at the site of block placement
- history of allergy to local anaesthetic drugs
- bleeding tendency or with evidence of coagulopathy
- pre-existing neurological deficit or neuromuscular disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Department of Anaesthesia & Intensive Care, Prince of Wales Hospital — Shatin
Identifiers
NCT: NCT04941664 · CREC.2021.184-T