Pain Management After Elective Shoulder Surgery

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Austrian Workers Compensation Board Trauma Center Vienna Meidling

Vienna, 1120, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydromorphone Hcl 4Mg Tab

Drug

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

Piritramide 15mg s.c.

Drug

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.

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)

Sponsors and collaborators

Lead sponsor

AUVA Traumazentrum Vienna Site UKH Meidling

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: May 31, 2018
Registry last updated: Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed