NCT03631914

Brief Summary

In a randomized controlled crossover study design, ultrasound guided infraclavicular brachial plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided PNB techniques will perform the blocks. 26 volunteers will be included. The primary objective is to investigate the effect of the NTT system on performance time, as a measure for improved block performance. Secondary objectives are the effects of the NTT system on dexterity, peripheral nerve block characteristics, subjective experience, and peripheral block performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

25 days

First QC Date

August 13, 2018

Last Update Submit

October 26, 2018

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Performance time

    Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing LA injection

    During peripheral nerve block procedure

Secondary Outcomes (9)

  • Distance travelled by needling hand

    During peripheral nerve block procedure

  • Distance travelled by probe hand

    During peripheral nerve block procedure

  • Number of intended movements (needling hand)

    During peripheral nerve block procedure

  • Number of intended movements (probe hand)

    During peripheral nerve block procedure

  • Block success

    30 minutes after peripheral nerve block procedure

  • +4 more secondary outcomes

Study Arms (2)

Active needle tip tracking

ACTIVE COMPARATOR

A needle tip tracking system is used when performing an ultrasound guided infraclavicular brachial plexus block.

Procedure: Infraclavicular brachial plexus block

Inactive needle tip tracking

OTHER

No needle tip tracking system is used when performing an ultrasound guided infraclavicular brachial plexus block.

Procedure: Infraclavicular brachial plexus block

Interventions

Infraclavicular brachial plexus blockPROCEDURE

An infraclavicular brachial plexus block is performed using ultrasound guidance.

Active needle tip trackingInactive needle tip tracking

Eligibility Criteria

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

You may qualify if:

  • ASA physical status 1 or 2
  • Volunteers that have given informed written consent

You may not qualify if:

  • BMI \< 18 kg/m2
  • BMI \> 35 kg/m2
  • Body weight \> 95 kg
  • Volunteers that cannot cooperate during the examination
  • Volunteers that do not speak or understand Norwegian language
  • Volunteers with neurologic disease, nerve- or vascular impairment
  • Volunteers with known coagulopathy
  • Volunteers that are allergic to Lidocaine or other local anaesthetic agents
  • Medications at the investigators discretion
  • Volunteers with concomitant medical treatments interfering with PNB treatment
  • Skin disease or infection affecting the whole-body surface or within the area of examination
  • Any reason why, in the opinion of the investigators, the volunteer should not participate
  • Subject participates in a potentially confounding drug or device trial during the course of the study
  • Pregnancy and lactation period
  • Women of childbearing potential who do not use an effective and secure method for birth control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

  • Kasine T, Romundstad L, Rosseland LA, Fagerland MW, Kessler P, Omenas IN, Holmberg A, Sauter AR. Ultrasonographic needle tip tracking for in-plane infraclavicular brachialis plexus blocks: a randomized controlled volunteer study. Reg Anesth Pain Med. 2020 Aug;45(8):634-639. doi: 10.1136/rapm-2020-101349. Epub 2020 Jun 14.

    PMID: 32540878DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal Investigator

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

September 3, 2018

Primary Completion

September 28, 2018

Study Completion

October 1, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

NO(1)