Clinical trial NCT04941664: Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Official title: Minimum Effective Local Anesthetic Volume of 0.5% Levobupivacaine Required for Ultrasound Guided Superior Trunk Block for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Diseases or Conditions
Keywords: Superior Trunk nerve block
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Changes of sensory & motor blockade (Readiness for surgery) of the upper extremity
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Minimum effective volume (ml) of local anesthetic agent
timeFrame: after nerve block till end of surgery
Secondary outcomes:
measure: Changes of motor blockade of the upper extremity
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Changes of sensory block of the upper extremity
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Percentage changes of the Diaphragmatic function
timeFrame: Baseline (before block) and at 30 minutes after block
measure: Changes of the Extensiveness of Diaphragmatic function
timeFrame: calculated after block
measure: Block performance time
timeFrame: assess once before surgery
measure: Discomfort score
timeFrame: assess once before surgery
measure: Paresthesia
timeFrame: during the period of undergoing the nerve block
measure: Complications
timeFrame: during the nerve block till the end of surgery
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Manoj K Karmakar, MD
role: PRINCIPAL_INVESTIGATOR
References: