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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01362075
Recruitment Status : Terminated (After 3 years of recruitment, the study was stopped due to time constraints.)
First Posted : May 27, 2011
Last Update Posted : August 8, 2014
University of Aarhus
Aarhus University Hospital
The Family Hede Nielsens Fund
Central Denmark Region
The Danish Rheumatism Association
Information provided by (Responsible Party):
Karen Toftdahl Bjørnholdt, Horsens Hospital

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Local infiltration analgesia Procedure: Interscalene catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Local infiltration analgesia Procedure: Local infiltration analgesia
150 ml ropivacaine, of which 100 ml is with adrenalin
Other Name: LIA

Active Comparator: Interscalene catheter 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.
Other Name: interscalene block

Primary Outcome Measures :
  1. Supplemental analgesics ingested [ Time Frame: First 24 hours postoperatively ]

Secondary Outcome Measures :
  1. Pain score [ Time Frame: First 72 hours postoperatively ]
  2. Supplemental analgesics ingested [ Time Frame: First 72 hours postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01362075

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Aarhus University Hospital, Aarhus Hospital
Aarhus, Denmark, DK-8000
Horsens Hospital
Horsens, Denmark, DK-8700
Sponsors and Collaborators
Horsens Hospital
University of Aarhus
Aarhus University Hospital
The Family Hede Nielsens Fund
Central Denmark Region
The Danish Rheumatism Association
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Principal Investigator: Karen T Bjørnholdt, MD Horsens Hospital
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Responsible Party: Karen Toftdahl Bjørnholdt, MD, Horsens Hospital Identifier: NCT01362075    
Other Study ID Numbers: KTB-001
M-20110084 ( Other Identifier: Central Denmark Region Ethics Committee )
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Keywords provided by Karen Toftdahl Bjørnholdt, Horsens Hospital:
Shoulder Arthroplasty
Local infiltration analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms