Pain Management After Shoulder Prosthesis: A Clinical Trial of Nerve Block and Local Infiltration

NCT ID: NCT01362075

Last Updated: 2014-08-08

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

TERMINATED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to determine the efficacy of local infiltration analgesia as compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The investigators hypothesize a reduced pain score and use of supplemental analgesic medication during the first three postoperative days using local infiltration analgesia.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Local infiltration analgesia

Group Type EXPERIMENTAL

Local infiltration analgesia

Intervention Type PROCEDURE

150 ml ropivacaine, of which 100 ml is with adrenalin

Interscalene catheter

Group Type ACTIVE_COMPARATOR

Interscalene catheter

Intervention Type PROCEDURE

7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours.

Interventions

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Local infiltration analgesia

150 ml ropivacaine, of which 100 ml is with adrenalin

Intervention Type PROCEDURE

Interscalene catheter

7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours.

Intervention Type PROCEDURE

Other Intervention Names

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LIA interscalene block

Eligibility Criteria

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Inclusion Criteria

* elective primary shoulder arthroplasty

Exclusion Criteria

* reverse or delta prosthesis
* recent fracture near the shoulder
* allergic to amid-type local analgesics
* operation not under general anaesthesia
* incompetent, pregnant, below 18 or above 90 years old
* severe chronic neurogenic pain or sensory disturbances in the shoulder
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

The Hede Nielsen Family Foundation

OTHER

Sponsor Role collaborator

Central Denmark Region

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Horsens Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Toftdahl Bjørnholdt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen T Bjørnholdt, MD

Role: PRINCIPAL_INVESTIGATOR

Horsens Hospital

Locations

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Aarhus University Hospital, Aarhus Hospital

Aarhus, Denmark, Denmark

Site Status

Horsens Hospital

Horsens, Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-20110084

Identifier Type: OTHER

Identifier Source: secondary_id

KTB-001

Identifier Type: -

Identifier Source: org_study_id

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