Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm FracturePhase 4NCT03476694
Ultrasound Guided Supraclavicular Brachial Plexus Block, Volume Comparison of Local Anaesthetics and Diaphragmatic Motility.
A Phase 4 study testing ultra sound guided supraclavicular brachial plexus block in people with Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
Brachial plexus block as done by landmark technique use large volume of local anaesthetics (at least 30-40 ml), leading to higher incidence of phrenic nerve involvement and diaphragmatic dysfunction. With use of ultrasound dose of local anaesthetic can be reduced. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture
- What is being tested?
- ultra sound guided supraclavicular brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jul 2018to 1 Feb 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years undergoing distal arm surgery
- American Society of Anesthesiologists physical status 1 to 3
- Able to give informed consent
- Body weight greater than 50 kg
Who cannot join
- Patient refusal for supraclavicular block.
- Inability to obtain informed consent.
- Contraindication to Brachial plexus block
- Pulmonary and cardiac disorders
- Pregnancy
- Allergy to local anesthetic
- Chest or shoulder deformities
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
B P Koirala Institute of Health science (BPKIHS)
Dharān, Koshi Zone, +977025
shambhu Adhikari, graduate, 9841104097, smvuadhikari@gmail.com
About this study
Official title: Effects of Various Volume of Local Anaesthetic Use for Ultrasound Guided Supraclavicular Brachial Plexus Block on Successful Blockade and Diaphragmatic Motility.
Brachial plexus block as done by landmark technique use large volume of local anaesthetics (at least 30-40 ml), leading to higher incidence of phrenic nerve involvement and diaphragmatic dysfunction. With use of ultrasound dose of local anaesthetic can be reduced. Volume as low as 20 ml when use by ultrasound guidance has shown to provide successful block with no hemidiaphragmatic palsy when compared with nerve stimulation technique. But no study has compared the different volumes of drug on success rate and diaphragmatic motility.So in this study , the investigators want to compare the incidence of hemidiaphragm paralysis and success of block with different volumes of local anaesthetic , so that the lowest effective dose with higher safety profile can be determined.
- Being tested
- ultra sound guided supraclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra sound guided supraclavicular brachial plexus blockProcedure or surgery
ultra sound guided supraclavicular brachial plexus block , comparing the volume of 0.75 % ropivacine in sucessful block and hemidiaphragmatic motilty.
| Study group | Role | What they receive |
|---|---|---|
| 20ml of 0.75% Ropivacine | Experimental | Not described Receives: Procedure: ultra sound guided supraclavicular brachial plexus block |
| 25ml of 0.75% Ropivacine | Experimental | Not described Receives: Procedure: ultra sound guided supraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemidiaphragmatic paralysis
grading of hemidiaphragmatic paralysis as, complete ,partial and no hemidiaphragmatic paralysis as reduction of diaphragmatic excursion greater than 75%, 25-75%, less than 25% respectively after sucessful blocade.
Measured: within 30 minutes after sucessfull blocade
Secondary outcomes (1)
sucessful blocade
ultrasound guided supraclavicular brachial plexus block using ropivacine and observing the complete block.
Measured: within 30 minutes of block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm FractureStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shambhu Adhikari, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476694
- Sponsor's protocol ID
- IRC/1091/017
- Status last verified
- Jun 2018
- First submitted
- 18 Mar 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Volume of Local Anaesthetic Use for Ultrasound Guided Supraclavicular Brachial Plexus Block on Successful Blockade and Diaphragmatic Motility.
- ClinicalTrials.gov ID
- NCT03476694
- Acronym / sponsor ID
- IRC/1091/017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 26 Mar 2018 (actual)
- 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.
Brachial plexus block as done by landmark technique use large volume of local anaesthetics (at least 30-40 ml), leading to higher incidence of phrenic nerve involvement and diaphragmatic dysfunction. With use of ultrasound dose of local anaesthetic can be reduced. Volume as low as 20 ml when use by ultrasound guidance has shown to provide successful block with no hemidiaphragmatic palsy when compared with nerve stimulation technique. But no study has compared the different volumes of drug on success rate and diaphragmatic motility.So in this study , the investigators want to compare the incidence of hemidiaphragm paralysis and success of block with different volumes of local anaesthetic , so that the lowest effective dose with higher safety profile can be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20ml of 0.75% Ropivacine | Experimental | Procedure: ultra sound guided supraclavicular brachial plexus block |
| 25ml of 0.75% Ropivacine | Experimental | Procedure: ultra sound guided supraclavicular brachial plexus block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years undergoing distal arm surgery
- American Society of Anesthesiologists physical status 1 to 3
- Able to give informed consent
- Body weight greater than 50 kg
Key exclusion criteria (7 listed)
- Patient refusal for supraclavicular block.
- Inability to obtain informed consent.
- Contraindication to Brachial plexus block
- Pulmonary and cardiac disorders
- Pregnancy
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 |
|---|---|---|
| ultra sound guided supraclavicular brachial plexus blockultra sound guided supraclavicular brachial plexus block , comparing the volume of 0.75 % ropivacine in sucessful block and hemidiaphragmatic motilty. | Procedure or surgery | 20ml of 0.75% Ropivacine, 25ml of 0.75% Ropivacine |
Primary outcome
hemidiaphragmatic paralysis
Time frame: within 30 minutes after sucessfull blocade
grading of hemidiaphragmatic paralysis as, complete ,partial and no hemidiaphragmatic paralysis as reduction of diaphragmatic excursion greater than 75%, 25-75%, less than 25% respectively after sucessful blocade.
1 secondary outcome
sucessful blocade
Time frame: within 30 minutes of block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: No
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.
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 ultra sound guided supraclavicular brachial plexus block in people with Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 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: status not confirmed, as of the sponsor's last update on 29 Jun 2018. 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 Nepal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shambhu adhikari, md resident (9779841104097, smvuadhikari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemidiaphragmatic paralysis (time frame: within 30 minutes after sucessfull blocade). 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 29 Jun 2018.