Anesthesia, RegionalPhase 4NCT02879916
Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery
A Phase 4 study testing Levobupivacaine and NaCl 0.9% in people with Anesthesia, Regional, run by University Hospital, Antwerp.
Trial summary
This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Regional
- What is being tested?
- Levobupivacaine and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Sep 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class 1 to 3
- Need for shoulder surgery
Who cannot join
- Mental retardation
- allergy for local anesthetics
- a medical reason as a contra-indication for NSAID use
- Diabetes mellitus
- peripheral neuropathy
- chronic analgetic use
- chronic pain patients
About this study
Official title: Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia
This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.
- Conditions
- Anesthesia, Regional
- Being tested
- Levobupivacaine, NaCl 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Inject 3ml of levobupavacaine into the stellate ganglion area
NaCl 0.9%Drug
Inject 3ml of NaCl 0.9% into the stellate ganglion area
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | NaCl 0.9% 3ml perineural stellate ganglion injection Receives: Drug: NaCl 0.9% |
| Stellate ganglion block | Active comparator | Levobupivacaine 3ml perineural stellate ganglion injection Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
The duration of analgesia assessed with quantitative sensory testing
Measured: 24 hours
Secondary outcomes (2)
Need for rescue analgesia
The timing of the need for rescue analgesia as requested by the patient
Measured: 24 hours
Duration of motor block
The duration of a motor block
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, RegionalStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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 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 (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Schepens, MD, University Hospital, Antwerp
- Investigators
- Luc Sermeus, MD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879916
- Sponsor's protocol ID
- 11/20/162
- Other IDs
- B300201111454
- Status last verified
- Oct 2016
- First submitted
- 11 Aug 2016
- Last updated
- 27 Oct 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 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia
- ClinicalTrials.gov ID
- NCT02879916
- Acronym / sponsor ID
- 11/20/162
- Conditions
- Anesthesia, Regional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Aug 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.
This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: NaCl 0.9%NaCl 0.9% 3ml perineural stellate ganglion injection |
| Stellate ganglion block | Active comparator | Drug: LevobupivacaineLevobupivacaine 3ml perineural stellate ganglion injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA class 1 to 3
- Need for shoulder surgery
Key exclusion criteria (7 listed)
- Mental retardation
- allergy for local anesthetics
- a medical reason as a contra-indication for NSAID use
- Diabetes mellitus
- peripheral neuropathy
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 |
|---|---|---|
| LevobupivacaineInject 3ml of levobupavacaine into the stellate ganglion area | Drug | Stellate ganglion block |
| NaCl 0.9%Inject 3ml of NaCl 0.9% into the stellate ganglion area | Drug | Placebo |
Primary outcome
Duration of analgesia
Time frame: 24 hours
The duration of analgesia assessed with quantitative sensory testing
2 secondary outcomes
Need for rescue analgesia
Time frame: 24 hours
Duration of motor block
Time frame: 24 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 27 Oct 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.
Luc Sermeus, MD principal investigator
Consultant
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine and NaCl 0.9% in people with Anesthesia, Regional, run by University Hospital, Antwerp.
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 7 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Duration of analgesia (time frame: 24 hours). 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 27 Oct 2016.