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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03476694
Other study ID # IRC/1091/017
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 1, 2018
Est. completion date February 1, 2019

Study information

Verified date June 2018
Source B.P. Koirala Institute of Health Sciences
Contact shambhu adhikari, md resident
Phone 9779841104097
Email smvuadhikari@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Nepal B P Koirala Institute of Health science (BPKIHS) Dharan Bazar Koshi Zone

Sponsors (1)

Lead Sponsor Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within 30 minutes after sucessfull blocade
Secondary sucessful blocade ultrasound guided supraclavicular brachial plexus block using ropivacine and observing the complete block. within 30 minutes of block