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

NCT ID: NCT03476694

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

20ml of 0.75% Ropivacine

Group Type EXPERIMENTAL

ultra sound guided supraclavicular brachial plexus block

Intervention Type PROCEDURE

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

25ml of 0.75% Ropivacine

Group Type EXPERIMENTAL

ultra sound guided supraclavicular brachial plexus block

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultra 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shambhu Adhikari

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

B P Koirala Institute of Health science (BPKIHS)

Dharān, Koshi Zone, Nepal

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Nepal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

shambhu adhikari, md resident

Role: CONTACT

Phone: 9779841104097

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

shambhu Adhikari, graduate

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRC/1091/017

Identifier Type: -

Identifier Source: org_study_id