NCT03329456

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2017

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

October 30, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 29, 2019

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

October 30, 2017

Last Update Submit

January 28, 2019

Conditions

Shoulder DiseaseAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Minimum effective volume (95%)

    30 minutes

Study Arms (1)

Ropivacaine

OTHER

Single arm intervention

Drug: Ropivacaine

Interventions

RopivacaineDRUG

Minimum effective volume

Ropivacaine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Related Publications (2)

  • 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.

    PMID: 28776638RESULT

  • 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.

    PMID: 30338518DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lars M Ytrebø, M.D Ph.D

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

October 30, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

January 29, 2019

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)