Shoulder FracturePhase 2NCT02182752
The Effect of Tramadol on Interscalene Brachial Plexus Block
A Phase 2 study testing Ropivacaine - Tramadol and Ropivacaine in people with Shoulder Fracture and Shoulder Dislocation, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Shoulder Fracture, Shoulder Dislocation, Rotator Cuff Injury
- What is being tested?
- Ropivacaine - Tramadol and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2013to Jan 2016
- Phase
- Phase 2
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder surgery
Who cannot join
- patients on opioids
- diabetes mellitus
- interscalene block contraindicated
- patient refusing regional anesthesia techniques
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.
- Being tested
- Ropivacaine - Tramadol, Ropivacaine
- Medical subject headings
- Shoulder Fractures, Shoulder Dislocation, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine - TramadolDrug
Interscalene block using ropivacaine plus tramadol
RopivacaineDrug
Interscalene block using ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine - Tramadol | Active comparator | Not described Receives: Drug: Ropivacaine - Tramadol |
| Ropivacaine | Active comparator | Not described Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Measured: 24 hours postoperatively
Secondary outcomes (3)
Persistent postoperative pain
Measured: 1 month postoperatively, 3 months postoperatively
Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement
Measured: 24 hours postoperatively
Evidence of sensory blockade resolution, confirmed by pin-prick test
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder FractureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Collaborators
- Aretaieion University Hospital
- Responsible party
- Principal investigator, Eleftheria Soulioti, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182752
- Sponsor's protocol ID
- 3694/27-3-13
- Status last verified
- Jan 2016
- First submitted
- 30 Jun 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
Publications
Lin E, Choi J, Hadzic A. Peripheral nerve blocks for outpatient surgery: evidence-based indications. Curr Opin Anaesthesiol. 2013 Aug;26(4):467-74. doi: 10.1097/ACO.0b013e328362baa4.
PubMed 23820103Bishop JY, Sprague M, Gelber J, Krol M, Rosenblatt MA, Gladstone JN, Flatow EL. Interscalene regional anesthesia for arthroscopic shoulder surgery: a safe and effective technique. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):567-70. doi: 10.1016/j.jse.2006.01.009.
PubMed 16979050
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
- ClinicalTrials.gov ID
- NCT02182752
- Acronym / sponsor ID
- 3694/27-3-13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Collaborators
- Aretaieion University Hospital
- Study start
- Apr 2013
- Primary completion
- Jan 2016 (actual)
- First posted
- 8 Jul 2014 (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 our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine - Tramadol | Active comparator | Drug: Ropivacaine - Tramadol |
| Ropivacaine | Active comparator | Drug: Ropivacaine |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shoulder surgery
Key exclusion criteria (4 listed)
- patients on opioids
- diabetes mellitus
- interscalene block contraindicated
- patient refusing regional anesthesia techniques
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 |
|---|---|---|
| Ropivacaine - TramadolInterscalene block using ropivacaine plus tramadol | Drug | Ropivacaine - Tramadol |
| RopivacaineInterscalene block using ropivacaine | Drug | Ropivacaine |
Primary outcome
Postoperative analgesia
Time frame: 24 hours postoperatively
3 secondary outcomes
Persistent postoperative pain
Time frame: 1 month postoperatively, 3 months postoperatively
Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement
Time frame: 24 hours postoperatively
Evidence of sensory blockade resolution, confirmed by pin-prick test
Time frame: 24 hours postoperatively
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 5 Jan 2016.
- Background: PubMed 23820103Lin E, Choi J, Hadzic A. Peripheral nerve blocks for outpatient surgery: evidence-based indications. Curr Opin Anaesthesiol. 2013 Aug;26(4):467-74. doi: 10.1097/ACO.0b013e328362baa4.
- Background: PubMed 16979050Bishop JY, Sprague M, Gelber J, Krol M, Rosenblatt MA, Gladstone JN, Flatow EL. Interscalene regional anesthesia for arthroscopic shoulder surgery: a safe and effective technique. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):567-70. doi: 10.1016/j.jse.2006.01.009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine - Tramadol and Ropivacaine in people with Shoulder Fracture and Shoulder Dislocation, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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 1 inclusion and 4 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 5 Jan 2016. 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 Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative analgesia (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02182752, which also lists 2 linked publications.
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 5 Jan 2016.