Postoperative PainPhase 4NCT03541759
Pain Management After Elective Shoulder Surgery
A Phase 4 study testing Hydromorphone Hcl 4Mg Tab and Piritramide 15mg s.c. in people with Postoperative Pain, run by AUVA Traumazentrum Vienna Site UKH Meidling at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Hydromorphone Hcl 4Mg Tab and Piritramide 15mg s.c.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 2 Jan 2018to 17 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Austrian Workers Compensation Board Trauma Center Vienna Meidling
Vienna, 1120
About this study
Official title: 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.
- Conditions
- Postoperative Pain
- Being tested
- Hydromorphone Hcl 4Mg Tab, Piritramide 15mg s.c.
- Keywords
- Elective shoulder surgery, hydromorphone, piritramide
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone Hcl 4Mg TabDrug
Also called Hydal retard 4Mg
Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS > 5.
Piritramide 15mg s.c.Drug
Also called Dipidolor 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Piritramide 15mg s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start2 Jan 2018
- Primary completion15 May 2018
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUVA Traumazentrum Vienna Site UKH Meidling
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Boesmueller, MD, PhD, AUVA Traumazentrum Vienna Site UKH Meidling
- Investigators
- Heinz Steltzer, MD, Prof., Study chair, Trauma Center Vienna Meidling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541759
- Sponsor's protocol ID
- 5/18-Anesthesiology
- Status last verified
- May 2018
- First submitted
- 17 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide
- ClinicalTrials.gov ID
- NCT03541759
- Acronym / sponsor ID
- 5/18-Anesthesiology
- Conditions
- Postoperative Pain
- Keywords
- Elective shoulder surgery, hydromorphone, piritramide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AUVA Traumazentrum Vienna Site UKH MeidlingUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone | Active comparator | Drug: Hydromorphone Hcl 4Mg TabHydromorphone 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 | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone Hcl 4Mg TabAlso: Hydal retard 4MgHydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS > 5. | Drug | Hydromorphone |
| Piritramide 15mg s.c.Also: Dipidolor 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. | Drug | Piritramide |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinz Steltzer, MD, Prof. study chair
Trauma Center Vienna Meidling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone Hcl 4Mg Tab and Piritramide 15mg s.c. in people with Postoperative Pain, run by AUVA Traumazentrum Vienna Site UKH Meidling at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain management after elective shoulder surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.