Postoperative PainPhase 2/3NCT01701921
The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery
A Phase 2/3 study testing Pregabalin 75mg and pregabalin 150 mg in people with Postoperative Pain, run by Larissa University Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin 75mg and pregabalin 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2011to Jun 2016
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age 18-85years who are undergoing cardiac surgery
Who cannot join
- Chronic pain syndromes
- Renal failure
- Age >85
- Allergy to Pregabalin
- Patients already taking pregabalin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery
The purpose of this study is to determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery.
Read the detailed description
Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and anxiolytic properties and was also used to treat neuropathic pain. In recent years it has been used as part of a multimodal management of acute postoperative pain after various types of surgery. We study the effect of pregabalin administered before cardiac surgery on acute and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various analgesic methods have been used from time to time (opioids, regional analgesia, non-steroidal anti-inflammatory drugs). In our research patients will be divided into three groups. The control group will receive a placebo capsule before surgery. The second group will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale (0-10) every day. Total morphine consumption by the patients as well as any other pain medications administered supplementary will be registered and compared between the different groups. Remaining postoperative pain will be assessed after 3 months. The results will be statistically analyzed in order to determine whether there is significant difference in pain management between the groups.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin 75mg, pregabalin 150 mg, Placebo
- Keywords
- cardiac surgery, pregabalin, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mgDrug
Also called Lyrica
Pregabalin 75mg by mouth one hour before surgery
pregabalin 150 mgDrug
Also called Lyrica
pregabalin 150mg by mouth one hour before surgery
PlaceboDrug
Also called Sugar pill
Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin 75 | Experimental | Pregabalin 75mg by mouth one hour before surgery Receives: Drug: Pregabalin 75mg |
| Pregabalin 150 | Active comparator | Pregabalin 150mg by mouth one hour before surgery Receives: Drug: pregabalin 150 mg |
| Sugar pill | Placebo comparator | Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption and other analgesics after surgery
Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded.
Measured: 24 hours after surgery
Secondary outcomes (1)
Remaining surgery related pain and analgesics consumption
Patients will be questioned three month after surgery about the presence of post operative pain, whether it affects their quality of life and whether they are receiving pain treatment
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionFeb 2016
- Study completionJun 2016
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aikaterini Bouzia, Larissa University Hospital
- Investigators
- Aikaterini A Bouzia, Medicine, Principal investigator, PhD candidate, School of Medicine, Univercity of LarissaGeorgios Vretzakis, Medicine, Study director, Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701921
- Sponsor's protocol ID
- 7/13-07-2011
- Status last verified
- Sep 2016
- First submitted
- 3 Oct 2012
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01701921
- Acronym / sponsor ID
- 7/13-07-2011
- Conditions
- Postoperative Pain
- Keywords
- cardiac surgery, pregabalin, postoperative pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Oct 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 determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery.
Detailed description
Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and anxiolytic properties and was also used to treat neuropathic pain. In recent years it has been used as part of a multimodal management of acute postoperative pain after various types of surgery. We study the effect of pregabalin administered before cardiac surgery on acute and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various analgesic methods have been used from time to time (opioids, regional analgesia, non-steroidal anti-inflammatory drugs). In our research patients will be divided into three groups. The control group will receive a placebo capsule before surgery. The second group will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale (0-10) every day. Total morphine consumption by the patients as well as any other pain medications administered supplementary will be registered and compared between the different groups. Remaining postoperative pain will be assessed after 3 months. The results will be statistically analyzed in order to determine whether there is significant difference in pain management between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregabalin 75 | Experimental | Drug: Pregabalin 75mgPregabalin 75mg by mouth one hour before surgery |
| Pregabalin 150 | Active comparator | Drug: pregabalin 150 mgPregabalin 150mg by mouth one hour before surgery |
| Sugar pill | Placebo comparator | Drug: PlaceboPlacebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients' age 18-85years who are undergoing cardiac surgery
Key exclusion criteria (5 listed)
- Chronic pain syndromes
- Renal failure
- Age >85
- Allergy to Pregabalin
- Patients already taking pregabalin
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 75mgAlso: LyricaPregabalin 75mg by mouth one hour before surgery | Drug | Pregabalin 75 |
| pregabalin 150 mgAlso: Lyricapregabalin 150mg by mouth one hour before surgery | Drug | Pregabalin 150 |
| PlaceboAlso: Sugar pillSugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery | Drug | Sugar pill |
Primary outcome
opioid consumption and other analgesics after surgery
Time frame: 24 hours after surgery
Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded.
1 secondary outcome
Remaining surgery related pain and analgesics consumption
Time frame: 3 months after surgery
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 12 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Aikaterini A Bouzia, Medicine principal investigator
PhD candidate, School of Medicine, Univercity of Larissa
Georgios Vretzakis, Medicine study director
Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pregabalin 75mg and pregabalin 150 mg in people with Postoperative Pain, run by Larissa University 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 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 12 Sep 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. 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 combined 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.
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 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 and other analgesics after surgery (time frame: 24 hours after 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 12 Sep 2016.