Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block

NCT04941664 | Recruiting

• 1 other identifier: CREC.2021.184-T
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Diseases or Conditions

Keywords

Superior Trunk nerve block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Changes of motor blockade of the upper extremity

  within 45 minutes after the block at 5 minutes interval

• Changes of sensory block of the upper extremity

  within 45 minutes after the block at 5 minutes interval

• Percentage changes of the Diaphragmatic function

  Baseline (before block) and at 30 minutes after block

• Changes of the Extensiveness of Diaphragmatic function

  calculated after block

• Block performance time

  assess once before surgery

Study Arms (1)

Levobupivacaine

OTHER

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

Interventions

0.5% levobupivacaine DRUG

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.

Also known as: Peripheral nerve block

Levobupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper shoulder arthroscopic rotator cuff repair procedure

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Manoj K Karmakar, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayla Wong, RN, BN

CONTACT

+85235056157; aylawong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be blinded to the amount of local anesthetic agent used. Outcome assessor assessing the outcomes will be blinded of the amount of local anaesthetic used.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 28, 2021
• Study Start: January 19, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 13, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)