PainNCT01442558
Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block
A study testing Bupivacaine in people with Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Sep 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III physical status
- Surgery of distal arm, forearm or hand
Who cannot join
- Skin infection near block injection site
- Allergy to local anesthetics
- Peripheral neuropathy upper limb
- INR of more than 1.4
- Thrombocytopenia
- Opioid dependency
Show all 9Show fewer
- Chronic pain syndrome
- Lack of orientation to person, place and time
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia
- Conditions
- Pain
- Being tested
- Bupivacaine
- Keywords
- relief, Intra-operative
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.
| Study group | Role | What they receive |
|---|---|---|
| SCL | Active comparator | Supraclavicular ultrasound-guided brachial plexus block Receives: Drug: Bupivacaine |
| ICL | Active comparator | Infraclavicular ultrasound-guided brachial plexus block Receives: Drug: Bupivacaine |
| AX | Active comparator | Axillary ultrasound-guided brachial plexus block Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of 3 different approaches to brachial plexus block
Whether or not there is need for additional analgesic drugs or need to switch to general anesthesia
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startDec 2011
- Primary completionSep 2013
- Study completionSep 2013
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 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442558
- Sponsor's protocol ID
- 0081-2011-HYMC
- Status last verified
- Sep 2011
- First submitted
- 22 Sep 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stav A, Reytman L, Stav MY, Portnoy I, Kantarovsky A, Galili O, Luboshitz S, Sevi R, Sternberg A. Comparison of the Supraclavicular, Infraclavicular and Axillary Approaches for Ultrasound-Guided Brachial Plexus Block for Surgical Anesthesia. Rambam Maimonides Med J. 2016 Apr 19;7(2):e0013. doi: 10.5041/RMMJ.10240.
PubMed 27101216
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT01442558
- Acronym / sponsor ID
- 0081-2011-HYMC
- Conditions
- Pain
- Keywords
- relief, Intra-operative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Sep 2011 (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 aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCL | Active comparator | Drug: BupivacaineSupraclavicular ultrasound-guided brachial plexus block |
| ICL | Active comparator | Drug: BupivacaineInfraclavicular ultrasound-guided brachial plexus block |
| AX | Active comparator | Drug: BupivacaineAxillary ultrasound-guided brachial plexus block |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III physical status
- Surgery of distal arm, forearm or hand
Key exclusion criteria (9 listed)
- Skin infection near block injection site
- Allergy to local anesthetics
- Peripheral neuropathy upper limb
- INR of more than 1.4
- Thrombocytopenia
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 |
|---|---|---|
| BupivacaineBupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves. | Drug | AX, ICL, SCL |
Primary outcome
Quality of 3 different approaches to brachial plexus block
Time frame: Immediate
Whether or not there is need for additional analgesic drugs or need to switch to general anesthesia
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 21 Jan 2015.
- Derived from this study: PubMed 27101216Stav A, Reytman L, Stav MY, Portnoy I, Kantarovsky A, Galili O, Luboshitz S, Sevi R, Sternberg A. Comparison of the Supraclavicular, Infraclavicular and Axillary Approaches for Ultrasound-Guided Brachial Plexus Block for Surgical Anesthesia. Rambam Maimonides Med J. 2016 Apr 19;7(2):e0013. doi: 10.5041/RMMJ.10240.
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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 study testing Bupivacaine in people with Pain, 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 2 inclusion and 9 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 21 Jan 2015. 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?
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?
Quality of 3 different approaches to brachial plexus block (time frame: Immediate). 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 NCT01442558, 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 21 Jan 2015.