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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03631914
Other study ID # 2018/1098
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2018
Est. completion date October 1, 2018

Study information

Verified date October 2018
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date October 1, 2018
Est. primary completion date September 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ASA physical status 1 or 2

- Volunteers that have given informed written consent

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Infraclavicular brachial plexus block
An infraclavicular brachial plexus block is performed using ultrasound guidance.

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (3)

Lead Sponsor Collaborator
Oslo University Hospital B. Braun Melsungen AG, Philips Medical Systems

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Distance travelled by needling hand Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection During peripheral nerve block procedure
Secondary Distance travelled by probe hand Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection During peripheral nerve block procedure
Secondary Number of intended movements (needling hand) Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection During peripheral nerve block procedure
Secondary Number of intended movements (probe hand) Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection During peripheral nerve block procedure
Secondary Block success A sensory block is defined as successful when there is analgesia (no sensation for touch) or anaesthesia (no sensation at all) involving all five nerves distal to the elbow 30 minutes after peripheral nerve block procedure
Secondary Block onset time Block onset time is defined as the time between the end of LA injection and development of a successful sensory block Within 60 minutes after peripheral nerve block procedure
Secondary Block duration Block duration is the time from the end of LA injection until at least one of the nerves involved in the sensory block has recovered Within 240 minutes after peripheral nerve block procedure
Secondary Quantified discomfort during block performance The participants are asked about discomfort during the block procedure using a numeric rating scale (scale range 0 - 10; 0 = no discomfort; 10 = worst discomfort imaginable) Immediately after peripheral nerve block procedure
Secondary Confidence in block success The anaesthetist is asked if he expects the block to be successful using a numeric rating scale (scale range 0 - 10; 0 = block success unlikely; 10 = block success very likely) Immediately after peripheral nerve block procedure
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