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

This study has been terminated.
(After 3 years of recruitment, the study was stopped due to time constraints.)
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01362075
First received: May 26, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention
Pain, Postoperative
Procedure: Local infiltration analgesia
Procedure: Interscalene catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia

Further study details as provided by Horsens Hospital:

Primary Outcome Measures:
  • Supplemental analgesics ingested [ Time Frame: First 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score [ Time Frame: First 72 hours postoperatively ] [ Designated as safety issue: No ]
  • Supplemental analgesics ingested [ Time Frame: First 72 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: July 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362075

Locations
Denmark
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
Investigators
Principal Investigator: Karen T Bjørnholdt, MD Horsens Hospital
  More Information

No publications provided

Responsible Party: Karen Toftdahl Bjørnholdt, MD, Horsens Hospital
ClinicalTrials.gov Identifier: NCT01362075     History of Changes
Other Study ID Numbers: KTB-001, M-20110084
Study First Received: May 26, 2011
Last Updated: August 7, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Horsens Hospital:
Shoulder Arthroplasty
Local infiltration analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014