PainPhase 4NCT02544893
Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block
A Phase 4 study testing bupivacaine, dexmedetomidin and serum physiologic in people with Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- bupivacaine, dexmedetomidin and serum physiologic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to Mar 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2
- 18-65 aged
- patient undergoing thoracotomy
Who cannot join
- chronic opioid consumption
- bupivacaine and dexmedetomidine allergies
- coagulopathy
- infection at the needle insertion side
- chronic liver and kidney disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Medicine Faculty
Kayseri, 38080
About this study
Official title: Postoperative Analgesic Effects of Using Bupivacaine Alone or Added Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block in Thoracotomy
we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy
Read the detailed description
paravertebral block is commonly used in the treatment for acute and chronic pain.The duration of paravertebral block could theoretically be prolonged with neurolytic agents. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.
- Conditions
- Pain
- Being tested
- bupivacaine, dexmedetomidin, serum physiologic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
Also called marcaine
21 ml 0.5 %bupivacaine is applied paravertebral space
dexmedetomidinDrug
Also called precedex
1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space
serum physiologicDrug
21 ml serum physiologic is applied paravertebral space
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | 0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on paravertebral block Receives: Drug: bupivacaine |
| dexmedetomidine | Active comparator | 100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on paravertebral block Receives: Drug: dexmedetomidin |
| serum phsyologic | Active comparator | 0,9% 21 ml serum physiologic Receives: Drug: serum physiologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
patient controlled analgesia
Measured: postoperative 24 hours
Secondary outcomes (1)
visual analog scale
visual analog scale
Measured: postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur Ünalan, TC Erciyes University
- Investigators
- esra n ünalan, resident, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544893
- Sponsor's protocol ID
- 2014/649
- Status last verified
- Aug 2016
- First submitted
- 7 Sep 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effects of Using Bupivacaine Alone or Added Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block in Thoracotomy
- ClinicalTrials.gov ID
- NCT02544893
- Acronym / sponsor ID
- 2014/649
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Sep 2015 (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.
we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy
Detailed description
paravertebral block is commonly used in the treatment for acute and chronic pain.The duration of paravertebral block could theoretically be prolonged with neurolytic agents. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Active comparator | Drug: bupivacaine0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on paravertebral block |
| dexmedetomidine | Active comparator | Drug: dexmedetomidin100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on paravertebral block |
| serum phsyologic | Active comparator | Drug: serum physiologic0,9% 21 ml serum physiologic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-2
- 18-65 aged
- patient undergoing thoracotomy
Key exclusion criteria (5 listed)
- chronic opioid consumption
- bupivacaine and dexmedetomidine allergies
- coagulopathy
- infection at the needle insertion side
- chronic liver and kidney disease
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 |
|---|---|---|
| bupivacaineAlso: marcaine21 ml 0.5 %bupivacaine is applied paravertebral space | Drug | bupivacaine |
| dexmedetomidinAlso: precedex1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space | Drug | dexmedetomidine |
| serum physiologic21 ml serum physiologic is applied paravertebral space | Drug | serum phsyologic |
Primary outcome
opioid consumption
Time frame: postoperative 24 hours
patient controlled analgesia
1 secondary outcome
visual analog scale
Time frame: postoperative 1 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 3 Aug 2016.
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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.
esra n ünalan, resident principal investigator
TC Erciyes University
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 bupivacaine, dexmedetomidin and serum physiologic in people with Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 3 Aug 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 Turkey (Türkiye). 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?
opioid consumption (time frame: postoperative 24 hours). 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 3 Aug 2016.