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Trial record 12 of 107 for:    ( Map: Nepal )

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

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ClinicalTrials.gov Identifier: NCT03476694
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Shambhu Adhikari, B.P. Koirala Institute of Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture Procedure: ultra sound guided supraclavicular brachial plexus block Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Various Volume of Local Anaesthetic Use for Ultrasound Guided Supraclavicular Brachial Plexus Block on Successful Blockade and Diaphragmatic Motility.
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis Ultrasound

Arm Intervention/treatment
Experimental: 20ml of 0.75% Ropivacine 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.

Experimental: 25ml of 0.75% Ropivacine 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. sucessful blocade [ Time Frame: within 30 minutes of block ]
    ultrasound guided supraclavicular brachial plexus block using ropivacine and observing the complete block.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476694


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

Locations
Nepal
B P Koirala Institute of Health science (BPKIHS) Recruiting
Dharān Bāzār, Koshi Zone, Nepal, +977025
Contact: shambhu Adhikari, graduate    9841104097    smvuadhikari@gmail.com   
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences

Responsible Party: Shambhu Adhikari, Resident doctor, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03476694     History of Changes
Other Study ID Numbers: IRC/1091/017
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Paresis
Humeral Fractures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arm Injuries
Wounds and Injuries
Fractures, Bone
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents