Clinical Trial: Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of Echogenic Versus Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block Success Rate: A Comparative Study

Brief Summary: In this prospective, randomized, double blinded study, the needle tip and needle shaft visibility of echogenic and nonechogenic needle were compared in ultrasound guided infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery were included in the study. Patients were randomised into two groups, group E (Echogenic) and group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted.

Detailed Summary:

The aim of the investigators study was to find out the better among the echogenic and nonechogenic needle in needle tip/shaft visibility and the block success rate in ultrasound guided infraclavicular brachial plexus block. Sixty patients were randomized into two groups, Group E (echogenic group) and Group NE (nonechogenic group) with thirty patients in each group. The ultrasound imaging of each nerve block was video recorded for later analysis. Recording commenced from skin puncture and stopped at the time of final needle removal (total block time). After each block the performer was asked to subjectively score the percentage time he had visualized the needle tip and needle shaft on a 5 point scale (1 = 0%-20%, 2 = 20%-40%, 3 = 40%- 60%, 4 = 60%-80%, 5 = 80%-100%). The recorded video was later analysed by an investigator. An objective measurement of percentage needle tip visibility and needle shaft visibility was calculated for each nerve block using the formula,

Time in view (needle tip) / total block time x 100

Time in view (needle shaft) / total block time x 100

The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted. Other block parameters were also compared.


Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome: Needle tip and shaft visibility [ Time Frame: Duration of Block procedure ]

Percentage Needle Tip & shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time*100


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of block procedure [ Time Frame: 5- 15 minutes. Start of skin puncture till the final needle removal ]
  • Time to onset of sensory blockade [ Time Frame: 0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test. ]
  • Time to onset of motor blockade [ Time Frame: 0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis. ]
  • Duration of sensory blockade [ Time Frame: 0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively. ]
  • Duration of motor blockade [ Time Frame: 0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions. ]
  • Block success rate of echogenic and Nonechogenic group. [ Time Frame: Duration of surgery ]


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: June 28, 2016
Date Started: July 2014
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016