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

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Local infiltration analgesia
Interscalene catheter
Sponsored by
Horsens Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Shoulder Arthroplasty, Local infiltration analgesia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Aarhus Hospital
  • Horsens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Local infiltration analgesia

Interscalene catheter

Arm Description

Outcomes

Primary Outcome Measures

Supplemental analgesics ingested

Secondary Outcome Measures

Pain score
Supplemental analgesics ingested

Full Information

First Posted
May 26, 2011
Last Updated
August 7, 2014
Sponsor
Horsens Hospital
Collaborators
University of Aarhus, Aarhus University Hospital, The Family Hede Nielsens Fund, Central Denmark Region, The Danish Rheumatism Association
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1. Study Identification

Unique Protocol Identification Number
NCT01362075
Brief Title
Pain Management After Shoulder Prosthesis: A Clinical Trial of Nerve Block and Local Infiltration
Official Title
Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
After 3 years of recruitment, the study was stopped due to time constraints.
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horsens Hospital
Collaborators
University of Aarhus, Aarhus University Hospital, The Family Hede Nielsens Fund, Central Denmark Region, The Danish Rheumatism Association

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Shoulder Arthroplasty, Local infiltration analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local infiltration analgesia
Arm Type
Experimental
Arm Title
Interscalene catheter
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Local infiltration analgesia
Other Intervention Name(s)
LIA
Intervention Description
150 ml ropivacaine, of which 100 ml is with adrenalin
Intervention Type
Procedure
Intervention Name(s)
Interscalene catheter
Other Intervention Name(s)
interscalene block
Intervention Description
7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours.
Primary Outcome Measure Information:
Title
Supplemental analgesics ingested
Time Frame
First 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain score
Time Frame
First 72 hours postoperatively
Title
Supplemental analgesics ingested
Time Frame
First 72 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen T Bjørnholdt, MD
Organizational Affiliation
Horsens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Aarhus Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Horsens Hospital
City
Horsens
ZIP/Postal Code
DK-8700
Country
Denmark

12. IPD Sharing Statement

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

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