Pain Management After Elective Shoulder Surgery

NCT03541759 | Completed Phase 4 DMC

• 1 other identifier: 5/18-Anesthesiology
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Elective shoulder surgery, hydromorphone, piritramide

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Study Arms (2)

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.

Drug: Hydromorphone Hcl 4Mg Tab

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.

Drug: Piritramide 15mg s.c.

Interventions

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.

Also known as: Hydal retard 4Mg

Hydromorphone

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.

Also known as: Dipidolor 15mg s.c.

Piritramide

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AUVA Traumazentrum Vienna Site UKH Meidling: lead

Study Sites (1)

Austrian Workers Compensation Board Trauma Center Vienna Meidling

Vienna, 1120, Austria

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone; Pirinitramide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Heinz Steltzer, MD, Prof.

  Trauma Center Vienna Meidling

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 31, 2018
• Study Start: January 2, 2018
• Primary Completion: May 15, 2018
• Study Completion: May 17, 2018
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)