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NCT03541759 Clinical Trial

Pain Management After Elective Shoulder Surgery

Postoperative Pain Clinical Trial

Official title:
Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03541759
Other study ID # 5/18-Anesthesiology
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2, 2018
Est. completion date May 17, 2018

Study information
Verified date May 2018
Source Austrian Workers’ Compensation Board Trauma Center Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postoperative pain management plays an important role in elective shoulder surgery. The aim of this randomized quantitative study is to compare two frequently used postoperative pain regimes (hydromorphone versus piritramide) regarding onset and duration after the effectiveness of the single-shot interscalene block has diminished.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date May 17, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- all patients undergoing elective shoulder surgery with a single-shot interscalene plexus brachialis block in addition to general anesthesia

- patients aged 18-99 years

- patients being capable of giving an informed consent to participation in this study

Exclusion Criteria:

- patients aged below 18 years

- patients with decompensated liver, heart or renal insufficiency

- patients with any kind of lung disease

- patients with a chronic pain syndrome

- patients with a previous pain medication with more than 3 drugs over more than 3 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Hydromorphone Hcl 4Mg Tab
Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS > 5.
• Piritramide 15mg s.c.
Dipidolor 15mg s.c. 2 times after surgery as basic medication. Dipidolor 7.5mg s.c. maximum 2 per 24h when NRS > 5.

Locations
Country Name City State
Austria Austrian Workers Compensation Board Trauma Center Vienna Meidling Vienna

Sponsors (1)
Lead Sponsor Collaborator
Austrian Workers’ Compensation Board Trauma Center Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain management after elective shoulder surgery Comparison of hydromorphone versus piritramide using the numeric rating scale (NRS; range 0 - 10 points; level 0 representing no pain; level 10 representing the highest pain level) 6 months
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