NCT02932670

Brief Summary

The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

October 12, 2016

Last Update Submit

March 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • success rate

    minimal composite score of 14 out of 16

    0-30 min

Study Arms (2)

costoclavicular inflaclavicular block

ACTIVE COMPARATOR

costoclavicular block with similar volume

Other: costoclavicular nerve block

costoclavicular block

EXPERIMENTAL

costoclavicular block with decreasing volume

Other: costoclavicular nerve block

Interventions

ultrasound-guided costoclavicular nerve block

costoclavicular blockcostoclavicular inflaclavicular block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 70 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 20 and 30

You may not qualify if:

  • adults who are unable to give their own consent
  • pre-existing neuropathy (assessed by history and physical examination)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
  • allergy to local anesthetics
  • pregnancy
  • prior surgery in the infraclavicular region
  • chronic pain syndromes requiring opioid intake at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G-1A4, Canada

Location

Related Publications (1)

  • Sotthisopha T, Elgueta MF, Samerchua A, Leurcharusmee P, Tiyaprasertkul W, Gordon A, Finlayson RJ, Tran DQ. Minimum Effective Volume of Lidocaine for Ultrasound-Guided Costoclavicular Block. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):571-574. doi: 10.1097/AAP.0000000000000629.

Study Officials

  • De QH Tran, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations