NCT03378323

Brief Summary

Patients will be randomized to one of two groups:

  1. 1.Multiple injection group: Axillary brachial plexus block with multiple injections, with the arm abducted, performed with the aid of ultrasound;
  2. 2.Single injection group: Axillary brachial plexus block with a single injection, with the arm placed behind the head and the elbow flexed, performed with the aid of ultrasound

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 Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

December 6, 2017

Last Update Submit

April 10, 2019

Conditions

Upper Extremity

Keywords

upper extremity surgery

Outcome Measures

Primary Outcomes (1)

  • Performance time

    Time in minutes from ultrasound probe placement to end of local anesthetic injection

    10 minutes

Secondary Outcomes (7)

  • Needling time

    15 minutes

  • Time to first analgesic request

    24 hours

  • Block-related complications

    24 hours

  • Postoperative opioid consumption on postoperative day 1

    24 hours

  • Pain scores at 12 hours postoperatively

    12 hours

  • +2 more secondary outcomes

Study Arms (2)

Multiple injection local anesthetic

ACTIVE COMPARATOR

Ultrasound guided axillary plexus block with multiple injections of local anesthetic

Drug: Multiple injection local anesthetic

Single injection local anesthetic

EXPERIMENTAL

Ultrasound guided axillary plexus block with a single injection of local anesthetic

Drug: Single injection local anesthetic

Interventions

Multiple injection local anestheticDRUG

Multiple injection local anesthetic

Multiple injection local anesthetic
Single injection local anestheticDRUG

Single injection local anesthetic

Single injection local anesthetic

Eligibility Criteria

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

You may qualify if:

  • Adult patients who undergo forearm or hand surgery under axillary brachial plexus block

You may not qualify if:

  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Renal or hepatic insufficiency
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du Valais

Sion, 1950, Switzerland

Location

Study Officials

  • Sina Grape, MD

    Hôpital du Valais

    PRINCIPAL INVESTIGATOR

  • Eric Albrecht, MD

    University of Lausanne Hospitals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 19, 2017

Study Start

July 1, 2018

Primary Completion

April 9, 2019

Study Completion

April 10, 2019

Last Updated

April 11, 2019

Record last verified: 2019-04

Locations

CH(1)