Postoperative PainPhase 4NCT00785382
Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
A Phase 4 study testing Pregabalin 150 mg in people with Postoperative Pain, run by IWK Health Centre at 1 site in Canada.
Trial summary
We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. Read more about this study
- Who is it for?
- Ages Up to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin 150 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Dec 2011
- 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 Up to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesia physical status class I \& II
- Age ¬< 65 years
- English-speaking
- Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)
Who cannot join
- Known or suspected allergy, sensitivity, or contraindication to pregabalin
- Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
- Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- History of a seizure disorder
- Pregnancy
- Current pre-operative therapy with pregabalin, gabapentin, or any opioid
- Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
- CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?
- Conditions
- Postoperative Pain
- Being tested
- Placebo, Pregabalin 150 mg
- Keywords
- Pain, Pregabalin, Lyrica, Breast surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Lactulose Placebo
Pregabalin 150 mgDrug
Also called Lyrica
150 mg Q12H x 2 doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: Pregabalin 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
Measured: 24 hours
Secondary outcomes (1)
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald George, IWK Health Centre
- Investigators
- Ronald B George, MD FRCPC, Principal investigator, IWK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785382
- Sponsor's protocol ID
- IWK-4298-2008
- Status last verified
- Oct 2012
- First submitted
- 4 Nov 2008
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT00785382
- Acronym / sponsor ID
- IWK-4298-2008
- Conditions
- Postoperative Pain
- Keywords
- Pain, Pregabalin, Lyrica, Breast surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Nov 2008 (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 hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?
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 |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: Pregabalin 150 mg |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesia physical status class I \& II
- Age ¬< 65 years
- English-speaking
- Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)
Key exclusion criteria (8 listed)
- Known or suspected allergy, sensitivity, or contraindication to pregabalin
- Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
- Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- History of a seizure disorder
- 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 |
|---|---|---|
| PlaceboLactulose Placebo | Drug | 1 |
| Pregabalin 150 mgAlso: Lyrica150 mg Q12H x 2 doses | Drug | 2 |
Primary outcome
The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
Time frame: 24 hours
1 secondary outcome
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Time frame: 48 hours
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 31 Oct 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.
Ronald B George, MD FRCPC principal investigator
IWK
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 150 mg in people with Postoperative Pain, run by IWK Health Centre 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 4 inclusion and 8 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 31 Oct 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 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?
The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. (time frame: 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 31 Oct 2012.