NCT01852396

Brief Summary

The goal of this study is to demonstrate that the novel retroclavicular approach is a safe, fast and effective technique for ultrasound-guided brachial plexus anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

1 month

First QC Date

April 22, 2013

Last Update Submit

August 9, 2013

Conditions

Describe Novel Approach to Brachial Plexus Anesthesia

Keywords

Infraclavicular blockBrachial PlexusRetroclavicular ApproachComplications of retroclavicular approachSuccess of retroclavicular approach

Outcome Measures

Primary Outcomes (1)

  • Success Rate of the Block

    Success is defined as complete sensory loss in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand.

    Assessed 30 minutes after block completion

Secondary Outcomes (11)

  • Surgical success rate

    Defined at the beginning of surgery until the end of surgery

  • Technique duration

    Time required in seconds for the retroclavicular block technique completion, assessed during block performance

  • Needle visualization

    Assessed after study completion, once all 50 patients will have been completed. Assessment will take place in the weeks following study completion

  • Patient discomfort

    Assessed immediately after the block

  • Patient satisfaction

    Assessed 48 hours after the block

  • +6 more secondary outcomes

Study Arms (1)

Regional anesthesia

EXPERIMENTAL

Recruit 50 patient having elbow, forearm, wrist or hand surgery and block brachial plexus using the novel retroclavicular approach

Procedure: Retroclavicular block

Interventions

Retroclavicular blockPROCEDURE

Retroclavicular approach ultrasound guided regional anesthesia

Regional anesthesia

Eligibility Criteria

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

You may qualify if:

  • Elective or Urgent Surgery of the hand, wrist or forearm
  • years and older
  • Ability to consent
  • American Society of Anesthesiologists class 1 to 3

You may not qualify if:

  • Infection at the site of infection
  • Abnormal anatomy at the site of infection
  • Coagulopathy
  • Severe Pulmonary Disease
  • Preexisting neurological symptom(s) in the operated arm
  • Pregnant patients
  • Patients weighing less than 50 kg
  • Allergy to amide type local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Study Officials

  • Pablo Echave, Doctor

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

April 22, 2013

First Posted

May 13, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

CA(1)