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CompletedNCT03329456LSIBUpdated Jan 29, 2019

MEV to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus

A Phase 4 interventional study of Ropivacaine in Shoulder Disease and Anesthesia, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-29.

Sponsored by University Hospital of North Norway · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The investigators have recently shown that LSIB in combination with a suprascapular and a cervical plexus block is a very good alternative for arthroscopic shoulder surgery. However, the investigators believe the total volume of local anesthetic for LSIB may be reduced. For shoulder surgery there is no need to block the medial cord and the investigators therefore hypothesize a significantly lower MEV95% by applying a selective lateral and posterior cord block

Read the detailed description

The MEV for a successful block in 50% of the participants will be determined by using the staircase up-and-down method introduced by Dixon and Massey. Logistic regression and probit transformation will be applied to estimate the MEV for a successful block in 95% of the participants.

02

Conditions studied

  • Shoulder Disease
  • Anesthesia
03

In context

Lead sponsor

University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • . Inclusion criteria are (ASA) physical status I-III, age between 18 and 70 years and (BMI) between 20 and 35 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria are pregnancy, patients with to regional anesthesia, allergy to LAs, patients taking opioids regularly due to chronic pain, use of anticoagulation drugs other than acetylsalicylic acid or dipyridamole, atrioventricular block, diabetes.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Other
    Ropivacaine

    Single arm intervention

    Drug: Ropivacaine

Interventions

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What researchers measure

Primary outcomes

  1. Minimum effective volume (95%)

    Time frame: 30 minutes

07

Study locations

1 site
  • University Hospital of North Norway
    Tromsø, Troms 9038, Norway
08

References and documents

Publications

  • Musso D, Flohr-Madsen S, Meknas K, Wilsgaard T, Ytrebo LM, Klaastad O. A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Acta Anaesthesiol Scand. 2017 Oct;61(9):1192-1202. doi: 10.1111/aas.12948. Epub 2017 Aug 4. PubMed 28776638 ↗
  • Musso D, Klaastad O, Wilsgaard T, Ytrebo LM. Brachial plexus block of the posterior and the lateral cord using ropivacaine 7.5 mg/mL. Acta Anaesthesiol Scand. 2019 Mar;63(3):389-395. doi: 10.1111/aas.13277. Epub 2018 Oct 18. PubMed 30338518 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Apr 2018, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2017
First posted
Nov 6, 2017
StartActual
Oct 30, 2017
Primary completionActual
Apr 1, 2018
CompletionActual
Apr 1, 2018
Last update
Jan 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03329456
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
Oct 30, 2017
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
Jan 29, 2019

Study contacts

Lars M Ytrebø, M.D Ph.D
principal investigator · University Hospital of North Norway

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ropivacaine

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