Post-thoracotomy PainPhase 4NCT01726205
Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy
A Phase 4 study testing Pregabalin and normal saline infusion, PRG and Pregabalin and ropivacaine 02% infusion in people with Post-thoracotomy Pain, run by Attikon Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-thoracotomy Pain
- What is being tested?
- Pregabalin and normal saline infusion, PRG and Pregabalin and ropivacaine 02% infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2008to May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for a thoracotomy,
Who cannot join
- age >70 years
- BMI > 30
- preoperative Hb < 10 mg/dL
- preexistent chronic pain
- neurologic disease
- chronic assumption of alcohol
- treatment with analgesics, anxiolytics, sedatives, antidepressants, or calcium channel inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy
- Conditions
- Post-thoracotomy Pain
- Being tested
- Pregabalin and normal saline infusion, PRG, Pregabalin and ropivacaine 02% infusion, Placebo drug, normal saline infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin and normal saline infusion, PRGDrug
Pregabalin and ropivacaine 02% infusionDrug
Placebo drug, normal saline infusionDrug
| Study group | Role | What they receive |
|---|---|---|
| pregabalin | Active comparator | perioperative pregabalin starting the evening before surgery, and for five days postoperatively Receives: Drug: Pregabalin and normal saline infusion, PRG |
| pregabalin and continuous wound infusion | Active comparator | Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter Receives: Drug: Pregabalin and ropivacaine 02% infusion |
| placebo | Placebo comparator | Placebo drug and normal saline infusion Receives: Drug: Placebo drug, normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
Measured: 5 days postoperatively
Secondary outcomes (1)
morphine consumption
Measured: 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startOct 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thoracotomy 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidiropoulou Tatiana, Attikon Hospital
- Investigators
- Tatiana Sidiropoulou, Principal investigator, Attikon HospitalEyaggelos Giavasopoulos, Principal investigator, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726205
- Sponsor's protocol ID
- PRGCWI1
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy
- ClinicalTrials.gov ID
- NCT01726205
- Acronym / sponsor ID
- PRGCWI1
- Conditions
- Post-thoracotomy Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Nov 2012 (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 assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pregabalin | Active comparator | Drug: Pregabalin and normal saline infusion, PRGperioperative pregabalin starting the evening before surgery, and for five days postoperatively |
| pregabalin and continuous wound infusion | Active comparator | Drug: Pregabalin and ropivacaine 02% infusionPregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter |
| placebo | Placebo comparator | Drug: Placebo drug, normal saline infusionPlacebo drug and normal saline infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for a thoracotomy,
Key exclusion criteria (7 listed)
- age >70 years
- BMI > 30
- preoperative Hb < 10 mg/dL
- preexistent chronic pain
- neurologic 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 |
|---|---|---|
| Pregabalin and normal saline infusion, PRG | Drug | pregabalin |
| Pregabalin and ropivacaine 02% infusion | Drug | pregabalin and continuous wound infusion |
| Placebo drug, normal saline infusion | Drug | placebo |
Primary outcome
Pain control
Time frame: 5 days postoperatively
1 secondary outcome
morphine consumption
Time frame: 3 days 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 14 Nov 2012.
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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.
Tatiana Sidiropoulou principal investigator
Attikon Hospital
Eyaggelos Giavasopoulos principal investigator
Attikon Hospital
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 Pregabalin and normal saline infusion, PRG and Pregabalin and ropivacaine 02% infusion in people with Post-thoracotomy Pain, run by Attikon 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 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 14 Nov 2012. 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. Some participants in this study may receive a placebo. 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 control (time frame: 5 days postoperatively). 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 14 Nov 2012.