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

Sponsor
Horsens Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01362075
Collaborator
University of Aarhus (Other), Aarhus University Hospital (Other), The Family Hede Nielsens Fund (Other), Central Denmark Region (Other), The Danish Rheumatism Association (Other)
74
Enrollment
2
Locations
2
Arms
39
Duration (Months)
37
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Local infiltration analgesia
  • Procedure: Interscalene catheter
 N/A

Study Design

Study Type:
Interventional
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 :
Jul 1, 2011
Actual Primary Completion Date :
Jul 1, 2014
Anticipated Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Local infiltration analgesia

Procedure: Local infiltration analgesia
150 ml ropivacaine, of which 100 ml is with adrenalin
Other Names:
  • 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 Names:
  • interscalene block

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Supplemental analgesics ingested [First 24 hours postoperatively]

    Secondary Outcome Measures

    1. Pain score [First 72 hours postoperatively]

    2. Supplemental analgesics ingested [First 72 hours postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital, Aarhus Hospital Aarhus Denmark DK-8000
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Toftdahl Bjørnholdt, MD, Horsens Hospital
    ClinicalTrials.gov Identifier:
    NCT01362075
    Other Study ID Numbers:
    • KTB-001
    • M-20110084
    First Posted:
    May 27, 2011
    Last Update Posted:
    Aug 8, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Karen Toftdahl Bjørnholdt, MD, Horsens Hospital
    Shoulder Arthroplasty
    Local infiltration analgesia
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Aug 8, 2014