Postoperative PainPhase 3NCT01025102
The Addition of Sufentanil Interscalene Block in Shoulder Surgery
A Phase 3 study testing Naropin 0.1% cum sufentanil in people with Postoperative Pain and Shoulder Surgery, run by Bent Gymoese Jorgensen at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Shoulder Surgery
- What is being tested?
- Naropin 0.1% cum sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age 18-80
- Shoulder surgery performed under interscalene block and general anesthesia
Who cannot join
- Contraindication of interscalene block
- Severe chronic obstructive lung disease
- Non-cooperative patient
- Intolerance to opioids
- Pregnancy
- Rheumatoid arthritis and diabetes with peripheral polyneuropathy
- Chronic pain or daily opioid intake
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Anesthetic Clinic, Frederiksberg University Hospital
Frederiksberg, Frederiksberg, 2000
About this study
Official title: Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery
The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.
Read the detailed description
The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery
- Conditions
- Postoperative Pain, Shoulder Surgery
- Being tested
- Naropin 0.1% cum sufentanil
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naropin 0.1% cum sufentanilDrug
Also called Local analgetic, Ropivacain
20ml of Naropin 0.1% cum sufentanil 1mikrog per ml
| Study group | Role | What they receive |
|---|---|---|
| Naropin 0.1% | Experimental | Not described Receives: Drug: Naropin 0.1% cum sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to experience of moderate to severe postoperative pain
Measured: On day of surgery and 1., 2. and 3. postop. day
Secondary outcomes (1)
Side effects
Measured: On day of surgery and 1., 2. and. 3. postop. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionNov 2012
- Study completionDec 2012
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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bent Gymoese Jorgensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bent Gymoese Jorgensen, Frederiksberg University Hospital
- Investigators
- Bent G Jørgensen, MD, Principal investigator, Anesthetic Clinic, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025102
- Sponsor's protocol ID
- gymoese007
- Status last verified
- Mar 2013
- First submitted
- 2 Dec 2009
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01025102
- Acronym / sponsor ID
- gymoese007
- Conditions
- Postoperative Pain, Shoulder Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bent Gymoese JorgensenUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Dec 2009 (estimated)
- 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.
The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.
Detailed description
The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naropin 0.1% | Experimental | Drug: Naropin 0.1% cum sufentanil |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- Age 18-80
- Shoulder surgery performed under interscalene block and general anesthesia
Key exclusion criteria (7 listed)
- Contraindication of interscalene block
- Severe chronic obstructive lung disease
- Non-cooperative patient
- Intolerance to opioids
- Pregnancy
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 |
|---|---|---|
| Naropin 0.1% cum sufentanilAlso: Local analgetic, Ropivacain20ml of Naropin 0.1% cum sufentanil 1mikrog per ml | Drug | Naropin 0.1% |
Primary outcome
Time to experience of moderate to severe postoperative pain
Time frame: On day of surgery and 1., 2. and 3. postop. day
1 secondary outcome
Side effects
Time frame: On day of surgery and 1., 2. and. 3. postop. day
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 2 Apr 2013.
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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.
Bent G Jørgensen, MD principal investigator
Anesthetic Clinic, Frederiksberg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naropin 0.1% cum sufentanil in people with Postoperative Pain and Shoulder Surgery, run by Bent Gymoese Jorgensen at 1 site in Denmark.
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 7 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 2 Apr 2013. 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to experience of moderate to severe postoperative pain (time frame: On day of surgery and 1., 2. and 3. postop. day). 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 2 Apr 2013.