Back to resultsPain Management After Elective Shoulder Surgery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Hydromorphone Hcl 4Mg Tab
Piritramide 15mg s.c.
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Elective shoulder surgery, hydromorphone, piritramide
Eligibility Criteria
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
Sites / Locations
- Austrian Workers Compensation Board Trauma Center Vienna Meidling
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hydromorphone
Piritramide
Arm Description
Hydromorphone Hcl 4 milligram (mg) Tab 2 times after surgery as basic medication. Hydromorphone Hcl 2.6mg maximum 2 per 24h when numeric rating scale (NRS) > 5.
Piritramide 15mg s.c. 2 times after surgery as basic medication. Piritramide 7.5mg s.c. maximum 2 per 24h when numeric rating scale (NRS) > 5.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03541759
First Posted
May 17, 2018
Last Updated
May 31, 2018
Sponsor
AUVA Traumazentrum Vienna Site UKH Meidling
1. Study Identification
Unique Protocol Identification Number
NCT03541759
Brief Title
Pain Management After Elective Shoulder Surgery
Official Title
Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AUVA Traumazentrum Vienna Site UKH Meidling
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Elective shoulder surgery, hydromorphone, piritramide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydromorphone
Arm Type
Active Comparator
Arm Description
Hydromorphone Hcl 4 milligram (mg) Tab 2 times after surgery as basic medication. Hydromorphone Hcl 2.6mg maximum 2 per 24h when numeric rating scale (NRS) > 5.
Arm Title
Piritramide
Arm Type
Active Comparator
Arm Description
Piritramide 15mg s.c. 2 times after surgery as basic medication. Piritramide 7.5mg s.c. maximum 2 per 24h when numeric rating scale (NRS) > 5.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone Hcl 4Mg Tab
Other Intervention Name(s)
Hydal retard 4Mg
Intervention Description
Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS > 5.
Intervention Type
Drug
Intervention Name(s)
Piritramide 15mg s.c.
Other Intervention Name(s)
Dipidolor 15mg s.c.
Intervention Description
Dipidolor 15mg s.c. 2 times after surgery as basic medication. Dipidolor 7.5mg s.c. maximum 2 per 24h when NRS > 5.
Primary Outcome Measure Information:
Title
Pain management after elective shoulder surgery
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Steltzer, MD, Prof.
Organizational Affiliation
Trauma Center Vienna Meidling
Official's Role
Study Chair
Facility Information:
Facility Name
Austrian Workers Compensation Board Trauma Center Vienna Meidling
City
Vienna
ZIP/Postal Code
1120
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain Management After Elective Shoulder Surgery
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