Ischemia Reperfusion InjuryPhase 4NCT03482544
The Effect of Pregabalin Given Preoperatively on the Tourniquet Induced Ischemia-reperfusion
A Phase 4 study testing Pragabalin in people with Ischemia Reperfusion Injury, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The application of tourniquet is indispensable for a bloodless surgical area in total knee arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can cause injury and then ischemia-reperfusion injury emerge. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemia Reperfusion Injury
- What is being tested?
- Pragabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2018to 15 Nov 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II
- Undergoing a total knee arthroplasty surgery
- Accept neuroaxial anesthesia for surgery
Who cannot join
- Any antiepileptic drug use
- Allergic reaction to pregabalin
- Severe hepatic, renal or gastrointestinal disorders
- Psychiatric disorders
- Pregnant women or breastfeeding
- NSAID or opioid drug use for a long time
- Diabetic or other neuropathic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage
The application of tourniquet is indispensable for a bloodless surgical area in total knee arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can cause injury and then ischemia-reperfusion injury emerge. Our aim in this study is to investigate effects of pregabalin, GABA analog drug, on the tourniquet induced ischemia-reperfusion injury.
Read the detailed description
Investigators will randomize patients into two groups. 1) Pregabalin group 2) Control group.
Investigators will give orally pregabalin 150 mg to the pregabalin group patients two times (first dose 1 day before surgery., second dose 1 hour before surgery). On the other hand placebo drug will give to the control group at the same times. Investigators will perform combined spinal epidural anesthesia for surgery and inject 3 cc 0.5% hyperbaric bupivacaine to subarachnoid space. Investigators will take blood samples for measurement of ischemia-reperfusion determinants, immediately before surgery, shortly before tourniquet deflation, and 20 minutes after tourniquet deflation. Then these samples will be analysed by ELISA method.
- Conditions
- Ischemia Reperfusion Injury
- Being tested
- Pragabalin, Placebo
- Keywords
- pregabalin, ischemia reperfusion injury, muscle
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PragabalinDrug
Also called pregabalin 150 mg, Lyrica, Pfezir, Almanya
pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.
PlaceboOther
Also called empty capsule
empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin Group | Active comparator | We will give 150 mg pregabalin capsule orally 1 day before surgery and 1 hour before surgery (totally two times) to the pregabalin group patients. Receives: Drug: Pragabalin |
| Control Group | Active comparator | In control group, we will empty the drug material from capsules and give only empty capsules to the control group patients at the same times. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia modified albumin
changes of ischemia modified albumin
Measured: before tournique application,just before tournique release, 20 minutes after tournique release
total oxidant status
changes of total oxidant status
Measured: before tournique application, just before tournique release, 20 minutes after tournique release
total antioxidant status
changes of total antioxidant status
Measured: before tournique application, just before tournique release, 20 minutes after tournique release
Secondary outcomes (1)
catalase
changes of catalase
Measured: before tournique application, just before tournique release, 20 minutes after tournique release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start10 Oct 2018
- Primary completion30 Oct 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemia Reperfusion InjuryStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Karaca, Baskent University
- Investigators
- Omer Karaca, Assist.Prof, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482544
- Sponsor's protocol ID
- KA16/10
- Status last verified
- Nov 2018
- First submitted
- 5 Mar 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davies SJ, Reichardt-Pascal SY, Vaughan D, Russell GI. Differential effect of ischaemia-reperfusion injury on anti-oxidant enzyme activity in the rat kidney. Exp Nephrol. 1995 Nov-Dec;3(6):348-54.
PubMed 8528679Vafapour M, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Talebi N, Shirdavani S. Effect of Gamma-aminobutyric acid on kidney injury induced by renal ischemia-reperfusion in male and female rats: Gender-related difference. Adv Biomed Res. 2015 Jul 27;4:158. doi: 10.4103/2277-9175.161585. eCollection 2015.
PubMed 26380243Talebi N, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Vafapour M. The Protective Effect of gamma-aminobutyric Acid on Kidney Injury Induced by Renal Ischemia-reperfusion in Ovariectomized Estradiol-treated Rats. Int J Prev Med. 2016 Jan 11;7:6. doi: 10.4103/2008-7802.173796. eCollection 2016.
PubMed 26941907
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage
- ClinicalTrials.gov ID
- NCT03482544
- Acronym / sponsor ID
- KA16/10
- Conditions
- Ischemia Reperfusion Injury
- Keywords
- pregabalin, ischemia reperfusion injury, muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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 application of tourniquet is indispensable for a bloodless surgical area in total knee arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can cause injury and then ischemia-reperfusion injury emerge. Our aim in this study is to investigate effects of pregabalin, GABA analog drug, on the tourniquet induced ischemia-reperfusion injury.
Detailed description
Investigators will randomize patients into two groups. 1) Pregabalin group 2) Control group.
Investigators will give orally pregabalin 150 mg to the pregabalin group patients two times (first dose 1 day before surgery., second dose 1 hour before surgery). On the other hand placebo drug will give to the control group at the same times. Investigators will perform combined spinal epidural anesthesia for surgery and inject 3 cc 0.5% hyperbaric bupivacaine to subarachnoid space. Investigators will take blood samples for measurement of ischemia-reperfusion determinants, immediately before surgery, shortly before tourniquet deflation, and 20 minutes after tourniquet deflation. Then these samples will be analysed by ELISA method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin Group | Active comparator | Drug: PragabalinWe will give 150 mg pregabalin capsule orally 1 day before surgery and 1 hour before surgery (totally two times) to the pregabalin group patients. |
| Control Group | Active comparator | Other: PlaceboIn control group, we will empty the drug material from capsules and give only empty capsules to the control group patients at the same times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I-II
- Undergoing a total knee arthroplasty surgery
- Accept neuroaxial anesthesia for surgery
Key exclusion criteria (7 listed)
- Any antiepileptic drug use
- Allergic reaction to pregabalin
- Severe hepatic, renal or gastrointestinal disorders
- Psychiatric disorders
- Pregnant women or breastfeeding
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 |
|---|---|---|
| PragabalinAlso: pregabalin 150 mg, Lyrica, Pfezir, Almanyapregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group. | Drug | Pregabalin Group |
| PlaceboAlso: empty capsuleempty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group. | Other | Control Group |
Primary outcome
ischemia modified albumin
Time frame: before tournique application,just before tournique release, 20 minutes after tournique release
changes of ischemia modified albumin
total oxidant status
Time frame: before tournique application, just before tournique release, 20 minutes after tournique release
changes of total oxidant status
total antioxidant status
Time frame: before tournique application, just before tournique release, 20 minutes after tournique release
changes of total antioxidant status
1 secondary outcome
catalase
Time frame: before tournique application, just before tournique release, 20 minutes after tournique release
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 19 Nov 2018.
- Background: PubMed 8528679Davies SJ, Reichardt-Pascal SY, Vaughan D, Russell GI. Differential effect of ischaemia-reperfusion injury on anti-oxidant enzyme activity in the rat kidney. Exp Nephrol. 1995 Nov-Dec;3(6):348-54.
- Background: PubMed 26380243Vafapour M, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Talebi N, Shirdavani S. Effect of Gamma-aminobutyric acid on kidney injury induced by renal ischemia-reperfusion in male and female rats: Gender-related difference. Adv Biomed Res. 2015 Jul 27;4:158. doi: 10.4103/2277-9175.161585. eCollection 2015.
- Background: PubMed 26941907Talebi N, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Vafapour M. The Protective Effect of gamma-aminobutyric Acid on Kidney Injury Induced by Renal Ischemia-reperfusion in Ovariectomized Estradiol-treated Rats. Int J Prev Med. 2016 Jan 11;7:6. doi: 10.4103/2008-7802.173796. eCollection 2016.
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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.
Omer Karaca, Assist.Prof principal investigator
Baskent University
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 Pragabalin in people with Ischemia Reperfusion Injury, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 19 Nov 2018. 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 Turkey (Türkiye). 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.
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?
ischemia modified albumin (time frame: before tournique application,just before tournique release, 20 minutes after tournique release). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482544, which also lists 3 linked publications.
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 19 Nov 2018.