NCT03314948

Brief Summary

The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

October 16, 2017

Last Update Submit

January 19, 2022

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Success rate of costoclavicular brachial plexus block

    Determine the success rate of the block in patients with body mass index greater than 30. Assess the effectiveness of the block by performing required assessments

    Within 45 minutes of completion of block placement

Secondary Outcomes (1)

  • Identification of costoclavicular space

    during placement of the block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing an elective hand or forearm surgery

You may qualify if:

  • to 80 years old, with American Society of Anesthesiologists physical status I to IV, undergoing elective hand or forearm surgery under a BPB will be enrolled for this study.

You may not qualify if:

  • Patient's refusal, American Society of Anesthesiologist physical status greater than IV, pregnancy, neuromuscular disease, prior surgery on the intraclavicular fossa, nerve injury or neurological disorders, bleeding tendency or evidence of coagulopathy, history of allergy to local anesthetic drugs, skin infection at the site of needle insertion, or contraindication to regional anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

Study Officials

  • Christopher Robards, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

October 16, 2017

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

US(1)