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

August 7, 2014 updated by: Karen Toftdahl Bjørnholdt, Horsens Hospital

Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus University Hospital, Aarhus Hospital
      • Horsens, Denmark, DK-8700
        • Horsens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Supplemental analgesics ingested
Time Frame: First 24 hours postoperatively
First 24 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horsens Hospital

Collaborators

Aarhus University Hospital
University of Aarhus
Central Denmark Region
The Danish Rheumatism Association
The Family Hede Nielsens Fund

Investigators

  • Principal Investigator: Karen T Bjørnholdt, MD, Horsens Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

May 26, 2011

First Posted (Estimate)

May 27, 2011

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTB-001
  • M-20110084 (Other Identifier: Central Denmark Region Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Local infiltration analgesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe