Trial | NCT03541759  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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.
Study Started
Jan 02
2018
Primary Completion
May 15
2018
Study Completion
May 17
2018
Last Update
Jun 01
2018

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.

  • Other names: Hydal retard 4Mg

Drug 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.

  • Other names: Dipidolor 15mg s.c.

Hydromorphone Active Comparator

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 Active Comparator

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.

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
No Results Posted