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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01362075
Enrollment
74
Registered
2011-05-27
Start date
2011-07-31
Completion date
2014-10-31
Last updated
2014-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Shoulder Arthroplasty, Local infiltration analgesia

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.

Interventions

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.

Sponsors

University of Aarhus
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
The Hede Nielsen Family Foundation
CollaboratorOTHER
Central Denmark Region
CollaboratorOTHER
The Danish Rheumatism Association
CollaboratorOTHER
Horsens Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frame
Supplemental analgesics ingestedFirst 24 hours postoperatively

Secondary

MeasureTime frame
Pain scoreFirst 72 hours postoperatively
Supplemental analgesics ingestedFirst 72 hours postoperatively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026