Ligament InjuryPhase 4NCT02035774
A Novel Selective Block of the Suprascapular Nerve
A Phase 4 study testing LSIB + SSNB in people with Ligament Injury and Fracture, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of the hand. The investigators think that this supination is caused by lateral rotation in the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ligament Injury, Fracture
- What is being tested?
- LSIB + SSNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists physical status (ASA) I- III
- age between 18 and 70 years
- body mass index between 20 and 36 kg/m2 scheduled for elective hand surgery.
Who cannot join
- We will measure the angle between wrist and horizontal plane while the patient is supine and the extended arm 75° abducted.
- Patient who are not able to pronate the hand ≤15° before block performance, will be excluded from the study.
- Patients will also be excluded if they are pregnant, have contraindications to regional anesthesia, coagulation disorder, allergy to local anesthetics (LA), atrioventricular block, peripheral neuropathy or drug-treated diabetes.
- Patients using other anticoagulation drugs than acetylsalicylic acids or dipyridamol will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of the hand. The investigators think that this supination is caused by lateral rotation in the shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal positioning of the hand for surgery on the dorsal side of the hand may be achieved by performing a SSN block (SSNB) in addition to the LSIB.
Read the detailed description
According to the hypothesis the investigators will perform a double blind , placebo controlled study to answer the research question above.
- Conditions
- Ligament Injury, Fracture
- Being tested
- LSIB + SSNB
- Keywords
- Brachial plexus block, Suprascapular nerve block
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSIB + SSNBProcedure or surgery
Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml) or LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml placebo, saline)
| Study group | Role | What they receive |
|---|---|---|
| LSIB +SSNB | Active comparator | Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml) Receives: Procedure: LSIB + SSNB |
| LSIB + placebo | Placebo comparator | Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml) + SSNB (4 ml saline) Receives: Procedure: LSIB + SSNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist angle
The investigators will assess the wrist angle 30 minutes after the two blocks (LSIB + SSNB)
Measured: 30 minutes
Secondary outcomes (1)
Satisfaction score
The investigators will ask the surgeons about his/her satisfaction with the hand position during surgery.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ligament InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Principal investigator, Lars Marius Ytrebo, University Hospital of North Norway
- Investigators
- Lars M Ytrebø, Professor, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035774
- Sponsor's protocol ID
- SSNB
- Status last verified
- Jun 2014
- First submitted
- 12 Jan 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hackworth RJ. A new and simplified approach to target the suprascapular nerve with ultrasound. J Clin Anesth. 2013 Jun;25(4):347-8. doi: 10.1016/j.jclinane.2013.01.006. Epub 2013 May 1. No abstract available.
PubMed 23643887Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U. Ultrasound-guided suprascapular nerve block, description of a novel supraclavicular approach. Reg Anesth Pain Med. 2012 May-Jun;37(3):325-8. doi: 10.1097/AAP.0b013e3182409168.
PubMed 22222688
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Selective Block of the Suprascapular Nerve
- ClinicalTrials.gov ID
- NCT02035774
- Acronym / sponsor ID
- SSNB
- Conditions
- Ligament Injury, Fracture
- Keywords
- Brachial plexus block, Suprascapular nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Jan 2014 (estimated)
- 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.
Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of the hand. The investigators think that this supination is caused by lateral rotation in the shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal positioning of the hand for surgery on the dorsal side of the hand may be achieved by performing a SSN block (SSNB) in addition to the LSIB.
Detailed description
According to the hypothesis the investigators will perform a double blind , placebo controlled study to answer the research question above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSIB +SSNB | Active comparator | Procedure: LSIB + SSNBPatients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml) |
| LSIB + placebo | Placebo comparator | Procedure: LSIB + SSNBPatients will receive LSIB (31 ml ropivacaine 7.5 mg/ml) + SSNB (4 ml saline) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with American Society of Anesthesiologists physical status (ASA) I- III
- age between 18 and 70 years
- body mass index between 20 and 36 kg/m2 scheduled for elective hand surgery.
Key exclusion criteria (4 listed)
- We will measure the angle between wrist and horizontal plane while the patient is supine and the extended arm 75° abducted.
- Patient who are not able to pronate the hand ≤15° before block performance, will be excluded from the study.
- Patients will also be excluded if they are pregnant, have contraindications to regional anesthesia, coagulation disorder, allergy to local anesthetics (LA), atrioventricular block, peripheral neuropathy or drug-treated diabetes.
- Patients using other anticoagulation drugs than acetylsalicylic acids or dipyridamol will be excluded.
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 |
|---|---|---|
| LSIB + SSNBPatients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml) or LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml placebo, saline) | Procedure or surgery | LSIB + placebo, LSIB +SSNB |
Primary outcome
Wrist angle
Time frame: 30 minutes
The investigators will assess the wrist angle 30 minutes after the two blocks (LSIB + SSNB)
1 secondary outcome
Satisfaction score
Time frame: 3 hours
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 17 Jun 2014.
- Background: PubMed 23643887Hackworth RJ. A new and simplified approach to target the suprascapular nerve with ultrasound. J Clin Anesth. 2013 Jun;25(4):347-8. doi: 10.1016/j.jclinane.2013.01.006. Epub 2013 May 1. No abstract available.
- Background: PubMed 22222688Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U. Ultrasound-guided suprascapular nerve block, description of a novel supraclavicular approach. Reg Anesth Pain Med. 2012 May-Jun;37(3):325-8. doi: 10.1097/AAP.0b013e3182409168.
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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.
Lars M Ytrebø, Professor principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LSIB + SSNB in people with Ligament Injury and Fracture, run by University Hospital of North Norway at 1 site in Norway.
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 3 inclusion and 4 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 17 Jun 2014. 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 Norway. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wrist angle (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035774, which also lists 2 linked publications.
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 17 Jun 2014.