Pain Management After Shoulder Prosthesis: A Clinical Tri... | NCT01362075

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

NCT01362075

Sponsor

Horsens Hospital

Status

Terminated

Last Update Posted

Aug 8, 2014Estimated

Enrollment

74Actual

Phase

Not Applicable

Conditions

Pain, Postoperative

Interventions

Local infiltration analgesia
Interscalene catheter

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
M-20110084	Other Identifier	Central Denmark Region Ethics Committee

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

After 3 years of recruitment, the study was stopped due to time constraints.

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Oct 2014Estimated

First Submitted Date

May 26, 2011

First Submission Date that Met QC Criteria

May 26, 2011

First Posted Date

May 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2014

Last Update Posted Date

Aug 8, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karen Toftdahl Bjørnholdt, MD, Horsens HospitalPrincipal Investigator

Lead Sponsor

Horsens HospitalOTHER

Collaborators

Name	Class
University of Aarhus	OTHER
Aarhus University Hospital	OTHER
The Hede Nielsen Family Foundation	OTHER
Central Denmark Region

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Local infiltration analgesia	Experimental		Procedure: Local infiltration analgesia
Interscalene catheter	Active Comparator		Procedure: Interscalene catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Local infiltration analgesia	Procedure	150 ml ropivacaine, of which 100 ml is with adrenalin	Local infiltration analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Supplemental analgesics ingested		First 24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Pain score		First 72 hours postoperatively
Supplemental analgesics ingested		First 72 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen T Bjørnholdt, MD	Horsens Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Aarhus Hospital		Aarhus	Denmark	DK-8000	Denmark
Horsens Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided