Pain Management After Elective Shoulder Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Hydromorphone Hcl 4Mg Tab; Drug: Piritramide 15mg s.c.

• Registration Number: NCT03541759
• Lead Sponsor: AUVA Traumazentrum Vienna Site UKH Meidling

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Status Verified: 2018-05
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-17
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-31
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydromorphone	Hydromorphone Hcl 4Mg Tab	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	Piritramide 15mg s.c.	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.

Primary Outcome Measures

Name	Time	Method
Pain management after elective shoulder surgery	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)

Trial Locations

Locations (1)

Austrian Workers Compensation Board Trauma Center Vienna Meidling; 🇦🇹 Vienna, Austria