Pain, PostoperativeNCT00572208
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
A study testing Gabapentin group in people with Pain, Postoperative, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Gabapentin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2008to Feb 2009
- Phase
- Interventional
- 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 elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby.
- Patients older than 18 years.
Who cannot join
- Patients unable to cooperate.
- Known allergy for Gabapentin or opioids.
- Acute pancreatitis
- History of gastric or peptic ulcer.
- History of alcohol or drug abuse.
- Chronic pain or daily intake of analgesics or corticosteroids.
Show all 11Show fewer
- Gastrointestinal obstruction
- Impaired liver function.
- Impaired kidney function.
- Previous operation with median sternotomy
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Mariann T Jensen, MD contact
Denmark2 sites, 2 recruiting
- Not yet recruiting
Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
Aarhus, 8200
Imran Parvaiz, MD, +45 40547377, imran@dadlnet.dk
Mariann T Jensen, MD, MTZ@sks.aaa.dk
- Recruiting
Cardiothoracic and vascular department, Skejby Sygehus
Aarhus
Mariann Tang Jensen, MD
About this study
In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.
The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.
Read more
Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.
We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.
- Conditions
- Pain, Postoperative
- Being tested
- Gabapentin group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin groupDrug
Gabapentin group:
Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)
- st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
- nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
- rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
- th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
- th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gabapentin group Receives: Drug: Gabapentin group |
| 2 | No intervention | placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: 1 month
Morphine consumption
Measured: 1 month
Secondary outcomes (4)
PONV
Measured: 1 month
Medication side effects
Measured: 1 month
Hospital stay
Measured: 1 month
VAS score and medication 30 days after the operation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vibeke Hjortdal, MD, Dr.sci, Principal investigator, Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572208
- Sponsor's protocol ID
- Gabapentin01
- Other IDs
- 2007-001479-12
- Status last verified
- Feb 2009
- First submitted
- 11 Dec 2007
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
- ClinicalTrials.gov ID
- NCT00572208
- Acronym / sponsor ID
- Gabapentin01
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 12 Dec 2007 (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.
In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.
The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.
Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.
We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.
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 | Active comparator | Drug: Gabapentin groupGabapentin group |
| 2 | No intervention | –placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby.
- Patients older than 18 years.
Key exclusion criteria (11 listed)
- Patients unable to cooperate.
- Known allergy for Gabapentin or opioids.
- Acute pancreatitis
- History of gastric or peptic ulcer.
- History of alcohol or drug abuse.
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 |
|---|---|---|
| Gabapentin groupGabapentin group: Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded) 1. st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 2. nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 3. rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 4. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 5. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) | Drug | 1 |
Primary outcome
Pain
Time frame: 1 month
Morphine consumption
Time frame: 1 month
4 secondary outcomes
PONV
Time frame: 1 month
Medication side effects
Time frame: 1 month
Hospital stay
Time frame: 1 month
VAS score and medication 30 days after the operation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
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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.
Mariann T Jensen, MD contact
Vibeke Hjortdal, MD, Dr.sci principal investigator
Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin group in people with Pain, Postoperative, run by Aarhus University Hospital at 2 sites in Denmark.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Parvaiz, MD (+45 40547377, imran@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 1 month). The study lists 2 primary outcomes in all. 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 13 Feb 2009.