Pain Management After Elective Shoulder Surgery

May 31, 2018 updated by: Sandra Boesmueller, MD, PhD, AUVA Traumazentrum Vienna Site UKH Meidling

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1120
        • Austrian Workers Compensation Board Trauma Center Vienna Meidling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AUVA Traumazentrum Vienna Site UKH Meidling

Investigators

  • Study Chair: Heinz Steltzer, MD, Prof., Trauma Center Vienna Meidling

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

May 17, 2018

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/18-Anesthesiology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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