Postoperative PainPhase 3PregabaNephNCT00957177
Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy
A Phase 3 study testing Pregabalin in people with Postoperative Pain, run by Medical University of Graz at 1 site in Austria.
Trial summary
Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented. Hyperalgesia is measured by von-Frey-Filaments. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative 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
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2009to Dec 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing elective nephrectomy
Who cannot join
- contraindication against pregabalin
- creatinine > 2.0 mg/dl
- GGT >165, AST >105, ALT >135
- peptic Ulcus
- haemorrhagic diathesis
- angina pectoris, myocardial infarction
Show all 9Show fewer
- stroke
- bronchial asthma
- opioid abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy
Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented.
Hyperalgesia is measured by von-Frey-Filaments.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
300mg pregabalin orally 1 hour before operation
PlaceboDrug
Also called Control
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Pregabalin group | Active comparator | Receiving 300mg pregabalin preoperative Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
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 posted12 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- More trials run by Medical University of GrazThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Sandner-Kiesling, MD, Study chair, Medical University of GrazHelmar Bornemann-Cimenti, MD, DSc, Principal investigator, Graz Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957177
- Sponsor's protocol ID
- PregabaNeph
- Acronym
- PregabaNeph
- Status last verified
- May 2011
- First submitted
- 11 Aug 2009
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy
- ClinicalTrials.gov ID
- NCT00957177
- Acronym / sponsor ID
- PregabaNeph / PregabaNeph
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Aug 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 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented.
Hyperalgesia is measured by von-Frey-Filaments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Pregabalin group | Active comparator | Drug: PregabalinReceiving 300mg pregabalin preoperative |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective nephrectomy
Key exclusion criteria (9 listed)
- contraindication against pregabalin
- creatinine > 2.0 mg/dl
- GGT >165, AST >105, ALT >135
- peptic Ulcus
- haemorrhagic diathesis
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: Lyrica300mg pregabalin orally 1 hour before operation | Drug | Pregabalin group |
| PlaceboAlso: ControlPlacebo | Drug | Placebo |
Primary outcome
postoperative opioid consumption
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 27 May 2011.
- Medical University of GrazLink provided by the sponsor.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
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
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Andreas Sandner-Kiesling, MD study chair
Medical University of Graz
Helmar Bornemann-Cimenti, MD, DSc principal investigator
Graz Medical University
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 Postoperative Pain, run by Medical University of Graz at 1 site in Austria.
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 9 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 27 May 2011. 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 Austria. 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 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?
postoperative opioid consumption (time frame: 48 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 27 May 2011.