ClinicalTrials.gg
Status unknownNCT03476694Updated Jun 29, 2018

Ultrasound Guided Supraclavicular Brachial Plexus Block, Volume Comparison of Local Anaesthetics and Diaphragmatic Motility.

A Phase 4 interventional study of ultra sound guided supraclavicular brachial plexus block in Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture, sponsored by B.P. Koirala Institute of Health Sciences. Status unknown at 1 site in Nepal. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-06-29.

Sponsored by B.P. Koirala Institute of Health Sciences · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture

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03

In context

Paresis

468 studies on the registry are indexed under Paresis; 117 are open to participants now.

This study's planned enrollment of 60 is above the median of 37 across 420 interventional studies indexed under Paresis.

Browse Paresis studies →

Lead sponsor

B.P. Koirala Institute of Health Sciences is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 60 years undergoing distal arm surgery
  • physical status 1 to 3
  • Able to give
  • Body weight greater than 50 kg

Exclusion criteria

Exclusion

  • Patient refusal for supraclavicular block.
  • Inability to obtain .
  • to Brachial plexus block
  • Pulmonary and cardiac disorders
  • Pregnancy
  • Allergy to local anesthetic
  • Chest or shoulder deformities
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    20ml of 0.75% Ropivacine

    Procedure: ultra sound guided supraclavicular brachial plexus block

  • Experimental
    25ml of 0.75% Ropivacine

    Procedure: ultra sound guided supraclavicular brachial plexus block

Interventions

  • Procedureultra sound guided supraclavicular brachial plexus block

    ultra sound guided supraclavicular brachial plexus block , comparing the volume of 0.75 % ropivacine in sucessful block and hemidiaphragmatic motilty.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 30 minutes after sucessfull blocade

Secondary outcomes

  1. sucessful blocade

    ultrasound guided supraclavicular brachial plexus block using ropivacine and observing the complete block.

    Time frame: within 30 minutes of block

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Study locations

1 of 1 sites recruiting
  • B P Koirala Institute of Health science (BPKIHS)
    Dharān Bāzār, Koshi Zone +977025, Nepal
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2018; primary completion for Feb 2019, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2018
First posted
Mar 26, 2018
StartEst.
Jul 1, 2018
Primary completionEst.
Feb 1, 2019
CompletionEst.
Feb 1, 2019
Last update
Jun 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03476694
Lead sponsor
B.P. Koirala Institute of Health Sciences
Responsible party
Shambhu Adhikari (Resident doctor, B.P. Koirala Institute of Health Sciences) — Principal investigator
First posted
Mar 26, 2018
Start date
Jul 1, 2018 (estimated)
Primary completion
Feb 1, 2019 (estimated)
Completion
Feb 1, 2019 (estimated)
Last update
Jun 29, 2018

Study contacts

shambhu adhikari, md resident
Contact
smvuadhikari@gmail.com
9779841104097

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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