Skip to main content
Clinical Trials/NCT03541759
NCT03541759
Completed
Phase 4

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

AUVA Traumazentrum Vienna Site UKH Meidling1 site in 1 country48 target enrollmentJanuary 2, 2018

Overview

Phase
Phase 4
Intervention
Hydromorphone Hcl 4Mg Tab
Conditions
Postoperative Pain
Sponsor
AUVA Traumazentrum Vienna Site UKH Meidling
Enrollment
48
Locations
1
Primary Endpoint
Pain management after elective shoulder surgery
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2018
End Date
May 17, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
AUVA Traumazentrum Vienna Site UKH Meidling
Responsible Party
Principal Investigator
Principal Investigator

Sandra Boesmueller, MD, PhD

Principal Investigator

AUVA Traumazentrum Vienna Site UKH Meidling

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

Arms & Interventions

Hydromorphone

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.

Intervention: Hydromorphone Hcl 4Mg Tab

Piritramide

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: Piritramide 15mg s.c.

Outcomes

Primary Outcomes

Pain management after elective shoulder surgery

Time Frame: 6 months

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)

Study Sites (1)

Loading locations...

Similar Trials