Musculoskeletal Diseases or ConditionsNCT04908371
Selective Trunk Block vs Hybrid Interscalene Supraclavicular BPB for Anaesthesia of the Entire Upper Extremity
A study testing Selective Trunk Block and Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB) in people with Musculoskeletal Diseases or Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objective of this study is to compare the clinical effectiveness in producing anesthesia of the whole upper limb between two regional blocks - Selective Trunk Block (SeTB) and Hybrid Interscalene Supraclavicular Brachial Plexus Block (hybrid IS-SC BPB). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Selective Trunk Block and Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- Dec 2022to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) physical status I-III
- undergoing elective or emergency upper extremity surgery involving the proximal humerus to distal hand or surgery involving any combination of these regions scheduled for a brachial plexus block
Who cannot join
- Patient refusal
- Pregnancy
- Skin infection at the site of block
- History of allergy to local anesthetic agents
- Bleeding tendency or with evidence of coagulopathy
- Pre-existing neurological deficit or neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
Shatin, New Territories
About this study
Official title: Selective Trunk Block Versus Hybrid Interscalene-Supraclavicular Brachial Plexus Block for Anaesthesia of the Entire Upper Extremity: A Randomized Double-Blind Controlled Trial
The objective of this study is to compare the clinical effectiveness in producing anesthesia of the whole upper limb between two regional blocks - Selective Trunk Block (SeTB) and Hybrid Interscalene Supraclavicular Brachial Plexus Block (hybrid IS-SC BPB).
Read the detailed description
Brachial plexus block (BPB) is frequently used as the sole anesthestic technique for upper extremity surgery. The choice of injection can be made from different approaches that often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the approach used. However, there is no single BPB technique that can consistently produce anesthesia of the whole ipsilateral upper extremity. Nevertheless, cases such as combined fracture of the upper humerus and forearm bones have to anesthetize the whole upper extremity for surgery or those with multiple comorbidities and unfit for general anesthesia. In these cases, multiple injections have to be made. Thus, a combined ultrasound guided (USG) interscalene-supraclavicular (IS-SC) BPB has to be used as the sole anesthetic for proximal humerus surgery but with a relatively large volume (35-50mL) of numbing medication, which often exceed the recommended maximum safety dose. Recently principal investigator has demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. As majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, principal investigator has proposed that selectively blocking the superior, middle and inferior trunks of the brachial plexus under ultrasound guidance, will produce anesthesia of the entire upper limb. Principal investigator refers this technique as selective trunk block (SeTB). The preliminary experience with SeTB for anesthesia of the entire upper limb with smaller volumes (25ml) of numbing medication is feasible and able to ensure total immobility of the whole upper limb that meets the essential requirement for surgery. In this study principal investigator hypothesizes that USG guided SeTB is not inferior to USG IS-SC BPB in terms of its ability to produce sensory-motor blockade.
The aim of this study is to compare the proportion of patients who develop "readiness for surgery" for 30 minutes between a SeTB and hybrid IS-SC BPB. In other words, comparing the clinical effectiveness in producing anesthesia of the whole ipsilateral upper limb between SeTB and hybrid IS-SC brachial plexus block.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Selective Trunk Block, Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB)
- Keywords
- Selective Trunk Block, Hybrid Interscalene-Supraclavicular Brachial Plexus Block
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Trunk BlockProcedure or surgery
Also called Drug (Xylocaine with adrenaline and Chirocaine)
It is one type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 20ml) injected at the trunks of the brachial plexus in order to produce the anesthesia of the whole upper extremity of the patients scheduled for upper limb surgery. SeTB will be performed as a "two-injection technique". One at the side of the neck (interscalene groove) of the affected upper limb, injections will be made near the superior trunk (5mL) and follow by redirection of the needle under ultrasound guidance to inject the LA to middle trunk (5mL). Then the second skin puncture will be made near the upper part mid-collar bone (supraclavicular fossa) to inject the LA to the inferior trunk (10mL).
Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB)Procedure or surgery
Also called Drug (Xylocaine with adrenaline and Chirocaine)
It is another type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 30ml) injected at the interscalene groove and supraclavicular fossa, so "two-injection technique" will be adopted. The first skin puncture will be near the side of the neck (interscalene groove) of the affected upper limb (15mL) and then the second skin puncture will also be made near the upper mid-collar bone (supraclavicular fossa) to inject 15mL of LA.
| Study group | Role | What they receive |
|---|---|---|
| Selective Trunk Block (SeTB) | Active comparator | Patients will lie flat on their back on the examination couch with the arm in neutral position and the head turned slightly to the opposite side. Ultrasound scan will be performed sequentially starting from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. After identifying the three trunks of the brachial plexus, ultrasound guided selective trunk block will be done using local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 20ml) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anesthetize the whole upper limb. Receives: Procedure: Selective Trunk Block |
| Interscalene-Supraclavicular Brachial Plexus Block (IS-SC-BPB) | Active comparator | Patients will lie flat on their back on the examination couch with the arm in neutral position and the head turned slightly to the opposite side. Ultrasound scan will be performed sequentially starting from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove. The unique sonomorphology of the C7 transverse process will be used as the key anatomical landmark to identify the individual elements of the brachial plexus. Under ultrasound guidance, local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 30ml) will be injected at the interscalene groove and at the supraclavicular fossa in order to anesthetize the whole upper limb. Receives: Procedure: Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness for surgery
An overall sensory score of =<30 (loss of sensation to cold stimulus (ice cube), NRS: 100-0, 100=normal sensation, 0=no sensation) and motor score of =<1 (3-points scale: 2=no block, 1=paresis, 0=paralysis) in all the nerves (C5 to T1) tested.
Sensation block assessment: 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.
Motor block assessment: C5 - elbow flexors (biceps, brachialis), C6 - wrist extensors (extensor carpi radialis longus and brevis), C7 - elbow extensors (triceps), C8 - finger flexors (flexor digitorum profundus) to the middle finger, T1 - small finger abductors (abductor digiti minimi).
Measured: within 45 minutes after the block at 5 minutes interval
Complete sensory-motor block
An overall sensory score and motor score of '0'. Sensation to coldness (ice) with sensory score of '0' [sensory score 100-0: sensory 100=normal sensation, and 0=no sensation] for 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.
Motor blockade will be graded using a 3-point scale: 2=no change, 1=reduced contraction (paresis), 0=paralysis. Motor block assessment at C5 - elbow flexors (biceps, brachialis), C6 - wrist extensors (extensor carpi radialis longus and brevis), C7 - elbow extensors (triceps), C8 - finger flexors (flexor digitorum profundus) to the middle finger, T1 - small finger abductors (abductor digiti minimi).
Measured: within 45 minutes after the block at 5 minutes interval
Secondary outcomes (6)
Changes of sensory block of each nerve (C5 to T1)
The time it takes to achieve a sensory block score of =<30 (loss of sensation to cold stimulus (ice cube), NRS: 100-0 100=normal sensation, 0=no sensation).
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.
Measured: within 45 minutes after the block at 5 minutes interval
Changes of motor block of each nerve (C5 to T1)
The time it takes to achieve a motor block score of =<1 (3-point motor grade: 2=no change, 1=reduced contraction (paresis), 0=paralysis).
C5 - elbow flexors (biceps, brachialis), C6 - wrist extensors (extensor carpi radialis longus and brevis), C7 - elbow extensors (triceps), C8 - finger flexors (flexor digitorum profundus) to the middle finger, T1 - small finger abductors (abductor digiti minimi).
Measured: within 45 minutes after the block at 5 minutes interval
Block performance time
the time taken from the start of the local anesthetic (LA) skin infiltration to the end of the LA injection for the block
Measured: within 30 minutes after entering the procedure room
Discomfort score
Discomfort experienced during the regional anesthesia using a numeric rating scale (NRS, 0 to 100, 0=no discomfort, 100=extreme discomfort)
Measured: immediately after the end of the block
Paresthesia
Any paresthesia experienced during the block will be assessed and recorded as a 'yes' or 'no' response
Measured: immediately after the end of the block
Complications
Any complications directly related to brachial plexus block (vascular or pleural puncture, ipsilateral Horner's syndrome, intraneural injection with nerve swelling or symptoms suggestive of local anesthetic toxicity) will be record.
Measured: within 45 minutes after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Published data indicated Selective Trunk Block is a better choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Diseases or ConditionsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to receive either a SeTB (SeTB group) or hybrid interscalene-supraclavicular BPB (IS-SC group) under ultrasound guidance. The randomization sequence will be generated using an online randomization software (www.randomization.com). The randomization sequence will be assigned as 1 = selective trunk block (SeTB group) and 2 = interscalene-supraclavicular BPB (IS-SC group). The group allocation will be prepared by a computer officer (third party) in the Department of Anaesthesia \& Intensive Care, of the Chinese University of Hong Kong.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Manoj K Karmakar, Chinese University of Hong Kong
- Investigators
- Manoj K Karmakar, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908371
- Sponsor's protocol ID
- SeTB vs IS-SC Ver2
- Status last verified
- Apr 2023
- First submitted
- 26 May 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Trunk Block Versus Hybrid Interscalene-Supraclavicular Brachial Plexus Block for Anaesthesia of the Entire Upper Extremity: A Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04908371
- Acronym / sponsor ID
- SeTB vs IS-SC Ver2
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- Selective Trunk Block, Hybrid Interscalene-Supraclavicular Brachial Plexus Block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Published data indicated Selective Trunk Block is a better choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the clinical effectiveness in producing anesthesia of the whole upper limb between two regional blocks - Selective Trunk Block (SeTB) and Hybrid Interscalene Supraclavicular Brachial Plexus Block (hybrid IS-SC BPB).
Detailed description
Brachial plexus block (BPB) is frequently used as the sole anesthestic technique for upper extremity surgery. The choice of injection can be made from different approaches that often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the approach used. However, there is no single BPB technique that can consistently produce anesthesia of the whole ipsilateral upper extremity. Nevertheless, cases such as combined fracture of the upper humerus and forearm bones have to anesthetize the whole upper extremity for surgery or those with multiple comorbidities and unfit for general anesthesia. In these cases, multiple injections have to be made. Thus, a combined ultrasound guided (USG) interscalene-supraclavicular (IS-SC) BPB has to be used as the sole anesthetic for proximal humerus surgery but with a relatively large volume (35-50mL) of numbing medication, which often exceed the recommended maximum safety dose. Recently principal investigator has demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. As majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, principal investigator has proposed that selectively blocking the superior, middle and inferior trunks of the brachial plexus under ultrasound guidance, will produce anesthesia of the entire upper limb. Principal investigator refers this technique as selective trunk block (SeTB). The preliminary experience with SeTB for anesthesia of the entire upper limb with smaller volumes (25ml) of numbing medication is feasible and able to ensure total immobility of the whole upper limb that meets the essential requirement for surgery. In this study principal investigator hypothesizes that USG guided SeTB is not inferior to USG IS-SC BPB in terms of its ability to produce sensory-motor blockade.
The aim of this study is to compare the proportion of patients who develop "readiness for surgery" for 30 minutes between a SeTB and hybrid IS-SC BPB. In other words, comparing the clinical effectiveness in producing anesthesia of the whole ipsilateral upper limb between SeTB and hybrid IS-SC brachial plexus block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to receive either a SeTB (SeTB group) or hybrid interscalene-supraclavicular BPB (IS-SC group) under ultrasound guidance. The randomization sequence will be generated using an online randomization software (www.randomization.com). The randomization sequence will be assigned as 1 = selective trunk block (SeTB group) and 2 = interscalene-supraclavicular BPB (IS-SC group). The group allocation will be prepared by a computer officer (third party) in the Department of Anaesthesia \& Intensive Care, of the Chinese University of Hong Kong.
| Arm | Type | Receives |
|---|---|---|
| Selective Trunk Block (SeTB) | Active comparator | Procedure: Selective Trunk BlockPatients will lie flat on their back on the examination couch with the arm in neutral position and the head turned slightly to the opposite side. Ultrasound scan will be performed sequentially starting from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. After identifying the three trunks of the brachial plexus, ultrasound guided selective trunk block will be done using local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 20ml) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anesthetize the whole upper limb. |
| Interscalene-Supraclavicular Brachial Plexus Block (IS-SC-BPB) | Active comparator | Procedure: Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB)Patients will lie flat on their back on the examination couch with the arm in neutral position and the head turned slightly to the opposite side. Ultrasound scan will be performed sequentially starting from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove. The unique sonomorphology of the C7 transverse process will be used as the key anatomical landmark to identify the individual elements of the brachial plexus. Under ultrasound guidance, local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 30ml) will be injected at the interscalene groove and at the supraclavicular fossa in order to anesthetize the whole upper limb. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anaesthesiologists (ASA) physical status I-III
- undergoing elective or emergency upper extremity surgery involving the proximal humerus to distal hand or surgery involving any combination of these regions scheduled for a brachial plexus block
Key exclusion criteria (6 listed)
- Patient refusal
- Pregnancy
- Skin infection at the site of block
- History of allergy to local anesthetic agents
- Bleeding tendency or with evidence of coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Trunk BlockAlso: Drug (Xylocaine with adrenaline and Chirocaine)It is one type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 20ml) injected at the trunks of the brachial plexus in order to produce the anesthesia of the whole upper extremity of the patients scheduled for upper limb surgery. SeTB will be performed as a "two-injection technique". One at the side of the neck (interscalene groove) of the affected upper limb, injections will be made near the superior trunk (5mL) and follow by redirection of the needle under ultrasound guidance to inject the LA to middle trunk (5mL). Then the second skin puncture will be made near the upper part mid-collar bone (supraclavicular fossa) to inject the LA to the inferior trunk (10mL). | Procedure or surgery | Selective Trunk Block (SeTB) |
| Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB)Also: Drug (Xylocaine with adrenaline and Chirocaine)It is another type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 30ml) injected at the interscalene groove and supraclavicular fossa, so "two-injection technique" will be adopted. The first skin puncture will be near the side of the neck (interscalene groove) of the affected upper limb (15mL) and then the second skin puncture will also be made near the upper mid-collar bone (supraclavicular fossa) to inject 15mL of LA. | Procedure or surgery | Interscalene-Supraclavicular Brachial Plexus Block (IS-SC-BPB) |
Primary outcome
Readiness for surgery
Time frame: within 45 minutes after the block at 5 minutes interval
An overall sensory score of =<30 (loss of sensation to cold stimulus (ice cube), NRS: 100-0, 100=normal sensation, 0=no sensation) and motor score of =<1 (3-points scale: 2=no block, 1=paresis, 0=paralysis) in all the nerves (C5 to T1) tested. Sensation block assessment: 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. Motor block assessment: C5 - elbow flexors (biceps, brachialis), C6 - wrist extensors (extensor carpi radialis longus and brevis), C7 - elbow extensors (triceps), C8 - finger flexors (flexor digitorum profundus) to the middle finger, T1 - small finger abductors (abductor digiti minimi).
Complete sensory-motor block
Time frame: within 45 minutes after the block at 5 minutes interval
An overall sensory score and motor score of '0'. Sensation to coldness (ice) with sensory score of '0' [sensory score 100-0: sensory 100=normal sensation, and 0=no sensation] for 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. Motor blockade will be graded using a 3-point scale: 2=no change, 1=reduced contraction (paresis), 0=paralysis. Motor block assessment at C5 - elbow flexors (biceps, brachialis), C6 - wrist extensors (extensor carpi radialis longus and brevis), C7 - elbow extensors (triceps), C8 - finger flexors (flexor digitorum profundus) to the middle finger, T1 - small finger abductors (abductor digiti minimi).
6 secondary outcomes
Changes of sensory block of each nerve (C5 to T1)
Time frame: within 45 minutes after the block at 5 minutes interval
Changes of motor block of each nerve (C5 to T1)
Time frame: within 45 minutes after the block at 5 minutes interval
Block performance time
Time frame: within 30 minutes after entering the procedure room
Discomfort score
Time frame: immediately after the end of the block
Paresthesia
Time frame: immediately after the end of the block
Complications
Time frame: within 45 minutes after the block
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj K Karmakar, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Trunk Block and Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB) in people with Musculoskeletal Diseases or Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness for surgery (time frame: within 45 minutes after the block at 5 minutes interval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.