Anesthetics, LocalPhase 4NCT02271867
Thermal QST for Interscale Block Evaluation
A Phase 4 study testing Interscalene block in people with Anesthetics, Local and Nerve Block, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthetics, Local, Nerve Block
- What is being tested?
- Interscalene block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2009to Aug 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible
Who cannot join
- contraindications for ISB
- diabetes mellitus
- peripheral neuropathy
- patients receiving chronic analgesic therapy
- contraindications for NSAID
- patients with an initial QST with abnormal values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thermal Quantitative Sensory Testing as a Method to Semi-quantitatively Assess the Neurosensory Effects of 3 Local Anesthetic Solutions in an Interscalene Block
Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.
- Conditions
- Anesthetics, Local, Nerve Block
- Being tested
- Interscalene block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene blockProcedure or surgery
An ultrasound guided ISB was performed with injection aimed to block the C5-root
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine 0,5% | Active comparator | Levobupivacaine 0,5% 15 ml once Receives: Procedure: Interscalene block |
| Levobupivacaine 0,5% with epinephrine | Active comparator | Levobupivacaine 0,5% with 1/200000 epinephrine 15 ml once Receives: Procedure: Interscalene block |
| Ropivacaine 0,75% | Active comparator | Ropivacaine 0,75% 15 ml once Receives: Procedure: Interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of sensory block
Measured: 24 hours after intervention
Secondary outcomes (4)
Degree of sensory stimulus detection threshold variation from baseline values
The higher the difference in detection threshold variation, the more intense the block. Measured as % change, where 100% change means no sensation on maximal QST stimulus (0°C for cold sensation and 50°C for warm sensation)
Measured: 24 hours after intervention
Block duration
Measured: 24 hours after intervention
Use of rescue medication
Measured: 24 hours after intervention
Presence of motor block
Measured: 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startJul 2009
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthetics, LocalStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271867
- Sponsor's protocol ID
- EC 9/25/113
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sermeus LA, Hans GH, Schepens T, Bosserez NM, Breebaart MB, Smitz CJ, Vercauteren MP. Thermal quantitative sensory testing to assess the sensory effects of three local anesthetic solutions in a randomized trial of interscalene blockade for shoulder surgery. Can J Anaesth. 2016 Jan;63(1):46-55. doi: 10.1007/s12630-015-0505-x. Epub 2015 Oct 16.
PubMed 26475166
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Quantitative Sensory Testing as a Method to Semi-quantitatively Assess the Neurosensory Effects of 3 Local Anesthetic Solutions in an Interscalene Block
- ClinicalTrials.gov ID
- NCT02271867
- Acronym / sponsor ID
- EC 9/25/113
- Conditions
- Anesthetics, Local, Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- First posted
- 22 Oct 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.
Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine 0,5% | Active comparator | Procedure: Interscalene blockLevobupivacaine 0,5% 15 ml once |
| Levobupivacaine 0,5% with epinephrine | Active comparator | Procedure: Interscalene blockLevobupivacaine 0,5% with 1/200000 epinephrine 15 ml once |
| Ropivacaine 0,75% | Active comparator | Procedure: Interscalene blockRopivacaine 0,75% 15 ml once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible
Key exclusion criteria (6 listed)
- contraindications for ISB
- diabetes mellitus
- peripheral neuropathy
- patients receiving chronic analgesic therapy
- contraindications for NSAID
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 |
|---|---|---|
| Interscalene blockAn ultrasound guided ISB was performed with injection aimed to block the C5-root | Procedure or surgery | Levobupivacaine 0,5%, Levobupivacaine 0,5% with epinephrine, Ropivacaine 0,75% |
Primary outcome
Presence of sensory block
Time frame: 24 hours after intervention
4 secondary outcomes
Degree of sensory stimulus detection threshold variation from baseline values
Time frame: 24 hours after intervention
Block duration
Time frame: 24 hours after intervention
Use of rescue medication
Time frame: 24 hours after intervention
Presence of motor block
Time frame: 24 hours after intervention
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 22 Oct 2014.
- Derived from this study: PubMed 26475166Sermeus LA, Hans GH, Schepens T, Bosserez NM, Breebaart MB, Smitz CJ, Vercauteren MP. Thermal quantitative sensory testing to assess the sensory effects of three local anesthetic solutions in a randomized trial of interscalene blockade for shoulder surgery. Can J Anaesth. 2016 Jan;63(1):46-55. doi: 10.1007/s12630-015-0505-x. Epub 2015 Oct 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interscalene block in people with Anesthetics, Local and Nerve Block, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 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 22 Oct 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 Belgium. 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.
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?
Presence of sensory block (time frame: 24 hours after intervention). 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 NCT02271867, which also lists 1 linked publication.
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 22 Oct 2014.