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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01362075
• Other study ID #: KTB-001
• Secondary ID: M-20110084
• Status: Terminated
• Phase: N/A
• First received: May 26, 2011
• Last updated: August 7, 2014
• Start date: July 2011
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Horsens Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Local infiltration analgesia
150 ml ropivacaine, of which 100 ml is with adrenalin
• 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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Aarhus Hospital	Aarhus
Denmark	Horsens Hospital	Horsens

Sponsors (6)

Lead Sponsor	Collaborator
Horsens Hospital	Aarhus University Hospital, Central Denmark Region, The Danish Rheumatism Association, The Family Hede Nielsens Fund, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supplemental analgesics ingested		First 24 hours postoperatively	No
Secondary	Pain score		First 72 hours postoperatively	No
Secondary	Supplemental analgesics ingested		First 72 hours postoperatively	No