Chronic PainPhase 3NCT00998816
The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome
A Phase 3 study testing Pregabalin in people with Chronic Pain, run by Queen's University at 1 site in Canada.
Trial summary
Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Oct 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III
Who cannot join
- Inability ot adhere to study protocol:
- intolerance or hypersensitivity to any agents to be used in the study, contraindication to thoracic epidural placement
- inability to respond to the study questionnaire
- renal insufficiency(serum creatinine > 1.5 upper limit of normal)
- Body Mass index > 40
- planned post-operative ventilation.
Show all 25Show fewer
- Confounding procedural factors which might affect validity of data:
- previous ipsilateral thoracotomy
- surgery for tumor extending into the chest wall
- rest pain in proposed surgical area pre-operatively
- chest tube in situ at time of surgery
- requirement for second thoracotomy or re-occurrence of disease after surgery *isolated pleuroscopy or pleurodesis procedures.
- Potential interaction with study medications and patient's current medications:
- current alcohol or other substance abuse
- chronic steroid use
- pre-existing chronic pain requiring chronic analgesic use
- history of seizure disorder requiring treatment with an anticonvulsant
- current therapy with thiazolidinedione class oral hypoglycemic agents (eg, Actos, Avandia or Avandamet)
- history of congestive heart failure
- major psychiatric disorder
- any contraindication to use of NSAIDs.
- Insufficient safety data in the patient population:
- patients requiring preoperative assistance or assistive device for ambulation, pregnant or breastfeeding
- weight <50 Kg
- dizziness while inpatient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).
Read the detailed description
A total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (Lyrica)1 hour prior to surgery, 12 hr after surgery and then every 12 hr for an additional 10 days. While in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. Patients will be re-assessed at 2, 4 and 6 months following surgery.
- Conditions
- Chronic Pain
- Being tested
- Pregabalin
- Keywords
- thoracotomy, chronic, pain, pregabalin, Lyrica
- Medical subject headings
- Chronic Pain, Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
pregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsules | Placebo comparator | one placebo capsule will be administered 1 hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12h BID for 10 days following lateral thoracotomy. Receives: Drug: Pregabalin |
| pregabalin capsules | Active comparator | Pregabalin capsules (150mg) will be administered one hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12 hours (BID) for 10 days following lateral thoracotomy. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic post thoracotomy pain syndrome
Measured: 6 months following surgery
Secondary outcomes (1)
During hospital stay: pain intensity, PEF and FEV1, patient satisfaction, medication side effects. At 2, 4, and 6 months: pain intensity, pain quality (neuropathic versus other), quality of life, pain interference with daily function
Measured: During hospital stay and at 2, 4, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startMay 2012
- Primary completionAug 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Jorge Zamora, Queen's University
- Investigators
- Jorge E Zamora, MD, Principal investigator, Queen's University/ Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998816
- Sponsor's protocol ID
- ANAE 153-09
- Status last verified
- Apr 2012
- First submitted
- 20 Oct 2009
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
- ClinicalTrials.gov ID
- NCT00998816
- Acronym / sponsor ID
- ANAE 153-09
- Conditions
- Chronic Pain
- Keywords
- thoracotomy, chronic, pain, pregabalin, Lyrica
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- May 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 21 Oct 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.
Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).
Detailed description
A total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (Lyrica)1 hour prior to surgery, 12 hr after surgery and then every 12 hr for an additional 10 days. While in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. Patients will be re-assessed at 2, 4 and 6 months following surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo capsules | Placebo comparator | Drug: Pregabalinone placebo capsule will be administered 1 hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12h BID for 10 days following lateral thoracotomy. |
| pregabalin capsules | Active comparator | Drug: PregabalinPregabalin capsules (150mg) will be administered one hour before lateral thoracotomy, 12 hours following the thoracotomy and then every 12 hours (BID) for 10 days following lateral thoracotomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III
Key exclusion criteria (25 listed)
- Inability ot adhere to study protocol:
- Confounding procedural factors which might affect validity of data:
- Potential interaction with study medications and patient's current medications:
- Insufficient safety data in the patient population:
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 |
|---|---|---|
| PregabalinAlso: Lyricapregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days. | Drug | Placebo capsules, pregabalin capsules |
Primary outcome
Incidence of chronic post thoracotomy pain syndrome
Time frame: 6 months following surgery
1 secondary outcome
During hospital stay: pain intensity, PEF and FEV1, patient satisfaction, medication side effects. At 2, 4, and 6 months: pain intensity, pain quality (neuropathic versus other), quality of life, pain interference with daily function
Time frame: During hospital stay and at 2, 4, and 6 months postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Jorge E Zamora, MD principal investigator
Queen's University/ Kingston General 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 Pregabalin in people with Chronic Pain, run by Queen's University at 1 site in Canada.
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 25 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: withdrawn, as of the sponsor's last update on 11 Apr 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 Canada. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of chronic post thoracotomy pain syndrome (time frame: 6 months following surgery). 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 11 Apr 2012.