Study Stopped
After 3 years of recruitment, the study was stopped due to time constraints.
Pain Management After Shoulder Prosthesis: A Clinical Trial of Nerve Block and Local Infiltration
2 other identifiers
interventional
74
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedAugust 8, 2014
August 1, 2014
3 years
May 26, 2011
August 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Supplemental analgesics ingested
First 24 hours postoperatively
Secondary Outcomes (2)
Pain score
First 72 hours postoperatively
Supplemental analgesics ingested
First 72 hours postoperatively
Study Arms (2)
Local infiltration analgesia
EXPERIMENTALInterscalene catheter
ACTIVE COMPARATORInterventions
150 ml ropivacaine, of which 100 ml is with adrenalin
7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours.
Eligibility Criteria
You may qualify if:
- elective primary shoulder arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Horsens Hospitallead
- University of Aarhuscollaborator
- Aarhus University Hospitalcollaborator
- The Hede Nielsen Family Foundationcollaborator
- Central Denmark Regioncollaborator
- The Danish Rheumatism Associationcollaborator
Study Sites (2)
Aarhus University Hospital, Aarhus Hospital
Aarhus, Denmark, DK-8000, Denmark
Horsens Hospital
Horsens, Denmark, DK-8700, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen T Bjørnholdt, MD
Horsens Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 27, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2014
Study Completion
October 1, 2014
Last Updated
August 8, 2014
Record last verified: 2014-08