MEV to Block the Posterior and Lateral Cords of the Infra... | NCT03329456

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

NCT03329456

Sponsor

University Hospital of North Norway

Status

Completed

Last Update Posted

Jan 29, 2019Actual

Enrollment

23Actual

Phase

Phase 4

Conditions

Shoulder Disease
Anesthesia

Interventions

Ropivacaine

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2017Actual

Primary Completion Date

Apr 1, 2018Actual

Completion Date

Apr 1, 2018Actual

First Submitted Date

Oct 30, 2017

First Submission Date that Met QC Criteria

Oct 30, 2017

First Posted Date

Nov 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2019

Last Update Posted Date

Jan 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ropivacaine	Other	Single arm intervention	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	Minimum effective volume	Ropivacaine

Measure	Description	Time Frame
Minimum effective volume (95%)		30 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

. Inclusion criteria are American Society of Anesthesiologists (ASA) physical status I-III, age between 18 and 70 years and body mass index (BMI) between 20 and 35 kg/m2.

Exclusion Criteria:

Exclusion criteria are pregnancy, patients with contraindications 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars M Ytrebø, M.D Ph.D	University Hospital of North Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of North Norway		Tromsø	Troms	9038	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28776638	Result	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.
30338518	Derived	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.

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds