A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery

NCT ID: NCT02809144

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Analyzing block effects of the lateral sagittal infraclavicular brachial plexus block(posterior and lateral chord), the investigators found it affecting all shoulder relevant nerves , except for the suprascapular and the supraclavicular nerves.

Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and block of the posterior and lateral chords infraclavicularly, the investigators believe this novel combination would provide anesthesia for patients scheduled for shoulder surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nerve block

One novel nerve block combination

Group Type OTHER

Nerve block

Intervention Type PROCEDURE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nerve block

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)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients scheduled for shoulder surgery.
* American Society of Anesthesiologist grad I-III,
* 18-70 years,
* BMI 20-35,

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lars Marius Ytrebo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lars Marius Ytrebø, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of North Norway

Tromsø, Troms, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0472

Identifier Type: -

Identifier Source: org_study_id