Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusal

pregnancy

skin infection at the site of block placement

history of allergy to local anaesthetic drugs

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: LevobupivacaineOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
within 45 minutes after the block at 5 minutes interval
2

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).

Time frame
after nerve block till end of surgery

Secondary outcomes

1

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.

Time frame
within 45 minutes after the block at 5 minutes interval
2

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.

Time frame
within 45 minutes after the block at 5 minutes interval
3

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).

Time frame
Baseline (before block) and at 30 minutes after block
4

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'.

Time frame
calculated after block

Other outcomes

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