Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MEV for Retroclavicular Approach to Infraclavicular Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03555786
Recruitment Status : Terminated (Failure of recruitment)
First Posted : June 14, 2018
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

Brief Summary:
In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Condition or disease Intervention/treatment
Bupivacaine Other: minimum effective volume

Detailed Description:
A "biased coin up-and-down sequential design" will be applied to assess the minimum effective volume in 90% of patients for the retroclavicular brachial plexus block. The first subject received 25 ml 0.5% bupivacaine . Each subsequent patient received a dose that depended on the response of the previous one. If the previous block is successful, the block will be performed either by a reduction of the volume by 2.5 ml with a probability ß = 0.11 or by a same dose of the previous one with a probability 1-ß = 0.89 in the next patient.

Layout table for study information
Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : September 1, 2018

Intervention Details:
  • Other: minimum effective volume
    The determination of MEV90 and its 95% confidence interval (CI) will be based on a "biased coin up-and-down sequential design


Primary Outcome Measures :
  1. The minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90) [ Time Frame: 30 minutes ]
    The determination of MEV90 and its 95% confidence interval (CI) will be based on a "biased coin up-and-down sequential design



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.
Criteria

Inclusion Criteria:

  • patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
  • American Society of Anesthesiologists class I, II or III

Exclusion Criteria:

  • patients <18 years old
  • >65 years old
  • body mass index (BMI) <20 or >35 kg/m2
  • inability to provide written informed consent
  • refusal of regional anesthesia
  • pregnancy
  • contraindication for regional anesthesia

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): NCT03555786


Locations
Layout table for location information
Turkey
Antalya Training and Research Hospital
Antalya, Turkey
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
Layout table for investigator information
Study Director: Ali Sait Kavakli, MD Antalya Training and Research Hospital
Layout table for additonal information
Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03555786    
Other Study ID Numbers: AntalyaTRH25
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No