PainNCT02809144
A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery
A study testing Nerve block in people with Pain, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2016to Nov 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for shoulder surgery.
- American Society of Anesthesiologist grad I-III,
- 18-70 years,
- BMI 20-35,
Who cannot join
- Pregnancy,
- coagulopathy,
- allergy to local anesthetics,
- atrioventricular block,
- peripheral neuropathy or drug-treated diabetes.
- Patients using anticoagulation other than acetylsalicylic acid or dipyridamol will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods.
Read the detailed description
Analyzing block effects of the lateral sagittal infraclavicular brachial plexus block(posterior and lateral chord), the investigators found it affecting all shoulder relevant nerves , except for the suprascapular and the supraclavicular nerves.
Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and block of the posterior and lateral chords infraclavicularly, the investigators believe this novel combination would provide anesthesia for patients scheduled for shoulder surgery.
- Conditions
- Pain
- Being tested
- Nerve block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Nerve block: 31 ml ropivacaine 7.5 mg/ml (Lateral sagittal infraclavicular brachial plexus block) + 4 ml ropivacaine 5 mg/ml (suprascapular nerve block) + 5 ml ropivacaine 5 mg/ml (superficial cervical plexus block)
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Other | One novel nerve block combination Receives: Procedure: Nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for general anaesthesia
Investigators will record the number of patients who need to be converted to general anaesthesia
Measured: Intraoperatively
Secondary outcomes (1)
Surgeons satisfaction with the working conditions
Graded in a) Good and b) Poor
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Marius Ytrebo, University Hospital of North Norway
- Investigators
- Lars Marius Ytrebø, MD PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809144
- Sponsor's protocol ID
- 0472
- Status last verified
- Dec 2016
- First submitted
- 25 May 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02809144
- Acronym / sponsor ID
- 0472
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 22 Jun 2016 (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.
Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods.
Detailed description
Analyzing block effects of the lateral sagittal infraclavicular brachial plexus block(posterior and lateral chord), the investigators found it affecting all shoulder relevant nerves , except for the suprascapular and the supraclavicular nerves.
Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and block of the posterior and lateral chords infraclavicularly, the investigators believe this novel combination would provide anesthesia for patients scheduled for shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Other | Procedure: Nerve blockOne novel nerve block combination |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for shoulder surgery.
- American Society of Anesthesiologist grad I-III,
- 18-70 years,
- BMI 20-35,
Key exclusion criteria (6 listed)
- Pregnancy,
- coagulopathy,
- allergy to local anesthetics,
- atrioventricular block,
- peripheral neuropathy or drug-treated diabetes.
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 |
|---|---|---|
| Nerve blockNerve block: 31 ml ropivacaine 7.5 mg/ml (Lateral sagittal infraclavicular brachial plexus block) + 4 ml ropivacaine 5 mg/ml (suprascapular nerve block) + 5 ml ropivacaine 5 mg/ml (superficial cervical plexus block) | Procedure or surgery | Nerve block |
Primary outcome
The need for general anaesthesia
Time frame: Intraoperatively
Investigators will record the number of patients who need to be converted to general anaesthesia
1 secondary outcome
Surgeons satisfaction with the working conditions
Time frame: Intraoperatively
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 6 Dec 2016.
- 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.
Lars Marius Ytrebø, MD PhD 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 study testing Nerve block in people with Pain, 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 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 6 Dec 2016. 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. 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?
The need for general anaesthesia (time frame: Intraoperatively). 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 6 Dec 2016.