The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy

NCT ID: NCT02173418

Last Updated: 2016-08-17

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine

Phrenic nerve block with Ropivacaine

Group Type EXPERIMENTAL

Phrenic nerve block with Ropivacaine

Intervention Type DRUG

Placebo

Phrenic nerve block with Sodium chloride

Group Type PLACEBO_COMPARATOR

Phrenic nerve block with saline

Intervention Type DRUG

Interventions

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Phrenic nerve block with Ropivacaine

Intervention Type DRUG

Phrenic nerve block with saline

Intervention Type DRUG

Other Intervention Names

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Naropin Sodium Chloride

Eligibility Criteria

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Inclusion Criteria

1. Patients planned for elective lobectomy or pneumonectomy
2. 18 years or more on the day of the operation
3. Danish skills appropriate for fulfilling preoperative questionnaires

Exclusion Criteria

1. Known contralateral paresis of the Phrenic nerve
2. Allergy to Ropivacaine or Sodium Chloride
3. Preoperative ipsilateral shoulder pain
4. Infection or eczema on the intervention site. Clinical decision
5. Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation
6. Pregnancy
7. Acute porphyria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region of Southern Denmark

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Læge Fritz Karners og hustrus Foundation

UNKNOWN

Sponsor Role collaborator

Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation

UNKNOWN

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Morten Rune Blichfeldt-Eckhardt

Afdelingslæge

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morten R Blichfeldt-Eckhardt, MD

Role: PRINCIPAL_INVESTIGATOR

Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark

Locations

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Departement of Anaesthesia and intensive care, Odense University Hospital

Odense, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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S-20120129

Identifier Type: OTHER

Identifier Source: secondary_id

2012-002844-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012-002844-25

Identifier Type: -

Identifier Source: org_study_id

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