Arthroscopic Shoulder SurgeryNCT03277326
Interscalene vs Anterior and Posterior Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries
A study testing ISB, aSSB and pSSB in people with Arthroscopic Shoulder Surgery and Interscalene Block, run by Changi General Hospital at 1 site in Singapore.
Trial summary
To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung function and analgesia Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arthroscopic Shoulder Surgery, Interscalene Block, Suprascapular Nerve Block
- What is being tested?
- ISB, aSSB and pSSB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Aug 2017to 7 Jul 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective arthroscopic shoulder surgery under general anaesthesia
- Patients 21 years old and above
- American Society of Anesthesiologists (ASA) physical status 1 to 3
- BMI 18-35 kg/m2
Who cannot join
- Patients unable to give consent or inability to communicate/ cooperate
- Patients with chronic use of strong opioids (morphine, oxycodone)
- Patients with allergy to local anaesthetics or any drugs included in the study
- Patients with contraindications for regional anaesthesia such as coagulopathy
- Patients with pre-existing neurological deficits in upper limb/ phrenic nerve palsy
- Patients with pre-existing lung disease (COPD, uncontrolled asthma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Controlled Trial Comparing Interscalene Versus Anterior and Posterior Approaches of Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries
To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung function and analgesia
Read the detailed description
Interscalene block (ISB) is commonly used to provide pain control for shoulder surgeries. However, it is associated with several side effects, in particular, a high incidence of phrenic nerve blockade.
The suprascapular nerve block (SSB) has been proposed as an alternative to the ISB as it has a lower likelihood of causing phrenic nerve blockade. There are 2 commonly used approaches for the suprascapular nerve block, anterior and posterior. The anterior approach may still result in some degree of impairment of lung function.
The primary aim is to assess the pulmonary function after performance of ISB, aSSB and pSSB. Secondary outcomes are analgesic effects and incidence of adverse effects of these blocks.
- Being tested
- ISB, aSSB, pSSB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISBProcedure or surgery
ISB block with 0.5% ropivicaine 15mls ( 45mg )
aSSBProcedure or surgery
aSSB block with 0.5% ropivicaine 15mls ( 45mg )
pSSBProcedure or surgery
pSSB block with 0.5% ropivicaine 15mls ( 45mg )
| Study group | Role | What they receive |
|---|---|---|
| ISB | Active comparator | Interscalene brachial plexus block Receives: Procedure: ISB |
| aSSB | Active comparator | Anterior Suprascapular Block Receives: Procedure: aSSB |
| pSSB | Active comparator | Posterior Suprascapular Block Receives: Procedure: pSSB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
To assess the pulmonary function after performance of interscalene, anterior and posterior approaches to the suprascapular block
Measured: 2 years
Secondary outcomes (1)
Analgesic effects and complications
Analgesic effect (pain scores, opioid consumption, opioid related side effects), degree of motor blockade and incidence of adverse effects of blocks (Horner's syndrome, hoarseness of voice)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start30 Aug 2017
- Primary completion11 Jun 2018
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder SurgeryStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yean Chin Lim, Principal investigator, CGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277326
- Sponsor's protocol ID
- 2017/2459
- Status last verified
- May 2019
- First submitted
- 7 Sep 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled Trial Comparing Interscalene Versus Anterior and Posterior Approaches of Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries
- ClinicalTrials.gov ID
- NCT03277326
- Acronym / sponsor ID
- 2017/2459
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 11 Sep 2017 (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.
To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung function and analgesia
Detailed description
Interscalene block (ISB) is commonly used to provide pain control for shoulder surgeries. However, it is associated with several side effects, in particular, a high incidence of phrenic nerve blockade.
The suprascapular nerve block (SSB) has been proposed as an alternative to the ISB as it has a lower likelihood of causing phrenic nerve blockade. There are 2 commonly used approaches for the suprascapular nerve block, anterior and posterior. The anterior approach may still result in some degree of impairment of lung function.
The primary aim is to assess the pulmonary function after performance of ISB, aSSB and pSSB. Secondary outcomes are analgesic effects and incidence of adverse effects of these blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ISB | Active comparator | Procedure: ISBInterscalene brachial plexus block |
| aSSB | Active comparator | Procedure: aSSBAnterior Suprascapular Block |
| pSSB | Active comparator | Procedure: pSSBPosterior Suprascapular Block |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective arthroscopic shoulder surgery under general anaesthesia
- Patients 21 years old and above
- American Society of Anesthesiologists (ASA) physical status 1 to 3
- BMI 18-35 kg/m2
Key exclusion criteria (6 listed)
- Patients unable to give consent or inability to communicate/ cooperate
- Patients with chronic use of strong opioids (morphine, oxycodone)
- Patients with allergy to local anaesthetics or any drugs included in the study
- Patients with contraindications for regional anaesthesia such as coagulopathy
- Patients with pre-existing neurological deficits in upper limb/ phrenic nerve palsy
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 |
|---|---|---|
| ISBISB block with 0.5% ropivicaine 15mls ( 45mg ) | Procedure or surgery | ISB |
| aSSBaSSB block with 0.5% ropivicaine 15mls ( 45mg ) | Procedure or surgery | aSSB |
| pSSBpSSB block with 0.5% ropivicaine 15mls ( 45mg ) | Procedure or surgery | pSSB |
Primary outcome
Pulmonary function
Time frame: 2 years
To assess the pulmonary function after performance of interscalene, anterior and posterior approaches to the suprascapular block
1 secondary outcome
Analgesic effects and complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: No
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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.
Yean Chin Lim principal investigator
CGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISB, aSSB and pSSB in people with Arthroscopic Shoulder Surgery and Interscalene Block, run by Changi General Hospital at 1 site in Singapore.
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 4 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: finished, as of the sponsor's last update on 7 May 2019. 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 Singapore. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulmonary function (time frame: 2 years). 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 7 May 2019.