Musculoskeletal Diseases or Conditions Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | August 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Anaesthesia & Intensive Care, Prince of Wales Hospital | Shatin | New Territories |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Discomfort score | the degree of discomfort during the nerve block (NRS: 0-100; 0= no discomfort, 100 = very uncomfortable) | assess once before surgery | |
Secondary | Paresthesia | Any incidence of paresthesia during the nerve block | during the period of undergoing the nerve block | |
Secondary | 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 |
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