NCT02809144

Brief Summary

Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable pain

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

May 25, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

May 25, 2015

Last Update Submit

December 5, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • The need for general anaesthesia

    Investigators will record the number of patients who need to be converted to general anaesthesia

    Intraoperatively

Secondary Outcomes (1)

  • Surgeons satisfaction with the working conditions

    Intraoperatively

Study Arms (1)

Nerve block

OTHER

One novel nerve block combination

Procedure: Nerve block

Interventions

Nerve blockPROCEDURE

Nerve block: 31 ml ropivacaine 7.5 mg/ml (Lateral sagittal infraclavicular brachial plexus block) + 4 ml ropivacaine 5 mg/ml (suprascapular nerve block) + 5 ml ropivacaine 5 mg/ml (superficial cervical plexus block)

Nerve block

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for shoulder surgery.
  • American Society of Anesthesiologist grad I-III,
  • years,
  • BMI 20-35,

You may not qualify if:

  • Pregnancy,
  • coagulopathy,
  • allergy to local anesthetics,
  • atrioventricular block,
  • peripheral neuropathy or drug-treated diabetes.
  • Patients using anticoagulation other than acetylsalicylic acid or dipyridamol will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

MeSH Terms

Conditions

Pain

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Lars Marius Ytrebø, MD PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2015

First Posted

June 22, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)