Pain Management After Elective Shoulder Surgery

NCT ID: NCT03541759

Last Updated: 2018-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-05-17

Brief Summary

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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

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hydromorphone Hcl 4Mg Tab

Intervention Type DRUG

Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS \> 5.

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.

Group Type ACTIVE_COMPARATOR

Piritramide 15mg s.c.

Intervention Type DRUG

Dipidolor 15mg s.c. 2 times after surgery as basic medication. Dipidolor 7.5mg s.c. maximum 2 per 24h when NRS \> 5.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Hydal retard 4Mg Dipidolor 15mg s.c.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AUVA Traumazentrum Vienna Site UKH Meidling

OTHER

Sponsor Role lead

Responsible Party

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Sandra Boesmueller, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heinz Steltzer, MD, Prof.

Role: STUDY_CHAIR

Trauma Center Vienna Meidling

Locations

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Austrian Workers Compensation Board Trauma Center Vienna Meidling

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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5/18-Anesthesiology

Identifier Type: -

Identifier Source: org_study_id

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