AnalgesiaNCT02190760
Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.
A study testing Dexamethasone and Bupivacaine in people with Analgesia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Dexamethasone and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-surgical patients for arthroscopic or open shoulder surgery
Who cannot join
- Skin infection near block site
- Allergy to local anesthetics
- Peripheral neuropathy
- Proven opioid dependency
- Coagulopathy
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of the Interscalene Brachial Plexus Block.
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect.
- Conditions
- Analgesia
- Being tested
- Dexamethasone, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I (ISB-P) | Active comparator | Interscalene block with perineural injection of dexamethasone 0.1 mg/kg Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| Group II (ISB-S) | Active comparator | Interscalene block with systemically injection of dexamethasone 0.1 mg/kg. Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| Group III - ISB-C | Active comparator | Interscalene block without adjuvant. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy DxaM Perineural
Duration of motor and sensory block.
Measured: One day
Secondary outcomes (1)
Efficacy of Systemic DxaM
Duration of motor and sensory block
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
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 AnalgesiaStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anatoly Stav, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190760
- Sponsor's protocol ID
- HYMC-13.7.14
- Status last verified
- Jul 2014
- First submitted
- 13 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.
PubMed 34554686
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of the Interscalene Brachial Plexus Block.
- ClinicalTrials.gov ID
- NCT02190760
- Acronym / sponsor ID
- HYMC-13.7.14
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 15 Jul 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.
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (ISB-P) | Active comparator | Drug: Dexamethasone, Drug: BupivacaineInterscalene block with perineural injection of dexamethasone 0.1 mg/kg |
| Group II (ISB-S) | Active comparator | Drug: Dexamethasone, Drug: BupivacaineInterscalene block with systemically injection of dexamethasone 0.1 mg/kg. |
| Group III - ISB-C | Active comparator | Drug: BupivacaineInterscalene block without adjuvant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-surgical patients for arthroscopic or open shoulder surgery
Key exclusion criteria (6 listed)
- Skin infection near block site
- Allergy to local anesthetics
- Peripheral neuropathy
- Proven opioid dependency
- Coagulopathy
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 |
|---|---|---|
| Dexamethasone | Drug | Group I (ISB-P), Group II (ISB-S) |
| Bupivacaine | Drug | Group I (ISB-P), Group II (ISB-S), Group III - ISB-C |
Primary outcome
Efficacy DxaM Perineural
Time frame: One day
Duration of motor and sensory block.
1 secondary outcome
Efficacy of Systemic DxaM
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Derived from this study: PubMed 34554686Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.
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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.
Anatoly Stav, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Bupivacaine in people with Analgesia, run by Hillel Yaffe Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 15 Jul 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anatoly Stav, MD (972-4-6304687, stav@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy DxaM Perineural (time frame: One day). 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 NCT02190760, 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 15 Jul 2014.