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

This study is currently recruiting participants.
Verified November 2012 by Horsens Hospital
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: November 13, 2012
Last verified: November 2012
History of Changes
  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 ]

Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362075

Contacts
Contact: Karen T Bjørnholdt, MD +45 2554 4547 karenbjo@rm.dk

Locations
Denmark
Aarhus University Hospital, Aarhus Hospital Recruiting
Aarhus, Denmark, DK-8000
Horsens Hospital Recruiting
Horsens, Denmark, DK-8700
Contact: Karen T Bjørnholdt, MD     +45 2554 4547     karenbjo@rm.dk    
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: November 13, 2012
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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013