Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block

Minimum Effective Local Anesthetic Volume of 0.5% Levobupivacaine Required for Ultrasound Guided Superior Trunk Block for Shoulder Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Drug: 0.5% levobupivacaine

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Winnie Samy, RN, BN, MSc; Phone Number: +85235052734; Email: wsamy@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Recruiting
      • Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
      • Contact: Winnie Samy, RN, BN, MSc; Phone Number: +85235052734; Email: wsamy@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Levobupivacaine; Superior trunk nerve block will be done under ultrasound guidance to patients scheduled for shoulder surgeries. Local anesthetic agent (0.5% levobupivacaine) 8ml will be injected at the superior trunk of the brachial plexus in order to produce surgical anesthesia or analgesia for shoulder surgeries.

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 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 2ml. The upper dose limit of the study to minimize the potential for local anesthetic systemic toxicity will be 16ml and the lower dose limit will be 4ml, which will be of no clinical importance.; Other Names: Peripheral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of sensory & motor blockade (Readiness for surgery) of the upper extremity	The first exact timing (in minutes) [Readiness for surgery] that an Overall sensory score =<30 (NRS: 0-100; 100=normal sensation, 0=no sensation) using ice test and a motor grade =<1 (3 point scale: 2=no block, 1=paresis, 0=paralysis) in the nerves (C5 to C6) tested that are supplied by superior trunk of brachial plexus. Sensation to coldness (ice) will be tested at C5 - Lateral (radial) side of the antecubital fossa (just proximal to elbow crease); C6 - Thumb, dorsal surface, proximal phalanx. Motor block will be graded using a 3-points scale: 2=no block, 1=paresis and 0=paralysis, and will be test at C5 - elbow flexors and C6 - wrist extensors. "Block failure" will be defined as inability to achieve "readiness for surgery" at 30 minutes after the completion of the block.	within 45 minutes after the block at 5 minutes interval
Minimum effective volume (ml) of local anesthetic agent	The lowest volume (in milliliters) of local anesthetic agent that can produce an effective superior trunk block for surgery. Effective superior trunk block is defined as an overall sensory score of NRS =<30 and a motor grade of =<1 during the assessment after the nerve block that can undergo surgery. Sensory assessment will be done by using ice (cold sensation) test in both dermatomes (C5, C6) and a motor grade of =<1 in both myotome (C5, C6) tested. Sensory block will be graded as 0 to 100 where 100 represents normal sensation and 0=no sensation to coldness (ice cube).	after nerve block till end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of motor blockade of the upper extremity	Motor blockade will be graded using a 3-point scale: 2=no block, 1=paresis and 0=paralysis. Motor blockade of each individual nerve in the anaesthetized upper extremity will be evaluated by testing C5 - elbow flexors, C6 - Wrist extensors, C7 - Elbow extensors, C8 - Finger flexors to the middle finger, and T1 - small finger abductors. Onset of Motor block for each nerve will be defined as the time it took to achieve motor score =<1.	within 45 minutes after the block at 5 minutes interval
Changes of sensory block of the upper extremity	Sensation to coldness (ice) will be test at C5- lateral (radial) side of the antecubital fossa (just proximal to elbow crease), C6 - Thumb, dorsal surface, proximal phalanx, C7 - middle finger, dorsal surface, proximal phalanx, C8 - Little finger, dorsal surface, proximal phalanx, and T1 - medial (ulnar) side of the antecubital) fossa, just proximal to the medial epicondyle of the humerus. Sensory block, defined as loss of sensation to cold (ice), will be graded using a numeric rating scale (NRS: 0-100, 100=normal sensation, 0=no sensation). Onset of sensory block for each nerve will be defined as the time that it took to achieve a sensory block score of NRS =<30.	within 45 minutes after the block at 5 minutes interval
Percentage changes of the Diaphragmatic function	Excursion of the ipsilateral hemidiaphragm will be measured by ultrasound machine in supine position via the anterior subcostal route. The movement of the diaphragm will be measured in centimetres. The range of diaphragmatic excursion will be recorded from the resting expiratory position to deep inspiration (sigh test) as will be the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The decrease in diaphragmatic excursion will be calculated as the difference (in %) in diaphragmatic excursion measured before and 30 minutes after superior trunk block (STB).	Baseline (before block) and at 30 minutes after block
Changes of the Extensiveness of Diaphragmatic function	After obtaining the percentage changes of the diaphragmatic function, if the reduction in diaphragmatic excursion of more than 75%, or no movement, or paradoxical movement will be considered as complete paresis. Reduction in diaphragmatic excursion of both sigh and sniff test between 25% and 75% will be considered as partial paresis and diaphragmatic excursion of less than 25% will be considered as 'no paresis'.	calculated after block
Block performance time	The time taken from the start of the local anesthetic skin infiltration to the end of the injection of study drug for the nerve block.	assess once before surgery
Discomfort score	the degree of discomfort during the nerve block (NRS: 0-100; 0= no discomfort, 100 = very uncomfortable)	assess once before surgery
Paresthesia	Any incidence of paresthesia during the nerve block	during the period of undergoing the nerve block
Complications	Any complications during and right after the nerve block directly related to local anesthetic toxicity, vascular or pleural puncture,intraneural injection with nerve swelling.	during the nerve block till the end of surgery

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Manoj K Karmakar, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Superior Trunk nerve block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: CREC.2021.184-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No