search
Back to results

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

Primary Purpose

Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture

Status
Unknown status
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
ultra sound guided supraclavicular brachial plexus block
Sponsored by
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • B P Koirala Institute of Health science (BPKIHS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

20ml of 0.75% Ropivacine

25ml of 0.75% Ropivacine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2018
Last Updated
June 28, 2018
Sponsor
B.P. Koirala Institute of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03476694
Brief Title
Ultrasound Guided Supraclavicular Brachial Plexus Block, Volume Comparison of Local Anaesthetics and Diaphragmatic Motility.
Official Title
Effects of Various Volume of Local Anaesthetic Use for Ultrasound Guided Supraclavicular Brachial Plexus Block on Successful Blockade and Diaphragmatic Motility.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20ml of 0.75% Ropivacine
Arm Type
Experimental
Arm Title
25ml of 0.75% Ropivacine
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
ultra sound guided supraclavicular brachial plexus block
Intervention Description
ultra sound guided supraclavicular brachial plexus block , comparing the volume of 0.75 % ropivacine in sucessful block and hemidiaphragmatic motilty.
Primary Outcome Measure Information:
Title
hemidiaphragmatic paralysis
Description
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 Outcome Measure Information:
Title
sucessful blocade
Description
ultrasound guided supraclavicular brachial plexus block using ropivacine and observing the complete block.
Time Frame
within 30 minutes of block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shambhu adhikari, md resident
Phone
9779841104097
Email
smvuadhikari@gmail.com
Facility Information:
Facility Name
B P Koirala Institute of Health science (BPKIHS)
City
Dharān Bāzār
State/Province
Koshi Zone
ZIP/Postal Code
+977025
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shambhu Adhikari, graduate
Phone
9841104097
Email
smvuadhikari@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs