Living Kidney Donors Undergoing VAMS-nephrectomyNCT02340455
Effect of Oral Pregabalin on Hyperalgesia and Post-operative Pain in Patients Undergoing Nephrectomy Surgery: Sex Differential Study
A study testing Pregabalin_male and Pregabalin_female in people with Living Kidney Donors Undergoing VAMS-nephrectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA, an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting hyperalgesia. If the GABA level can be maintained at certain level, the progression into hyperalgesia can be averted. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Living Kidney Donors Undergoing VAMS-nephrectomy
- What is being tested?
- Pregabalin_male and Pregabalin_female
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Dec 2016
- 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18, <51 years
- healthy patients accepted for video-assisted living donor nephrectomy
Who cannot join
- Female patients who are pregnant or menopause
- Patients undergoing hormonal therapy
- Patients having neurologic disease or already taking GABA related drugs (pregabalin, gabapentin), or taking opioid drugs
- Insulin resistant diabetes
- Renal deficiency (eGFR < 60 ml/min/1.73 m2)
- Emergency operation, hemodynamically unstable patients
- Foreigner
- allergic to medication given in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA, an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting hyperalgesia. If the GABA level can be maintained at certain level, the progression into hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the effective postoperative pain management and the prevention of hyperalgesia from pregabalin, GABA analogue, and the possible sex difference in such effects of pregabalin.
- Being tested
- Pregabalin_male, Pregabalin_female, Placebo_Men, Placebo_Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin_maleDrug
Pregabalin 150mg bid 1day Men
Pregabalin_femaleDrug
Pregabalin 150mg bid 1day Women
Placebo_MenDrug
Placebo durg
Placebo_WomenDrug
Placebo_Women
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin_male | Experimental | Not described Receives: Drug: Pregabalin_male |
| Pregabalin_female | Experimental | Not described Receives: Drug: Pregabalin_female |
| Placebo_male | Active comparator | Not described Receives: Drug: Placebo_Men |
| Placebo_female | Active comparator | Not described Receives: Drug: Placebo_Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical threshold
Mechanical threshold can be measured using von Frey filaments at both incision site and non-dominant arm
Measured: from 1 day before op to postop 48 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: To rebalance the study plan because it is not desirable to set up comparators using placebo.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Kidney Donors Undergoing VAMS-nephrectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340455
- Sponsor's protocol ID
- 4-2014-0907
- Status last verified
- Feb 2019
- First submitted
- 13 Jan 2015
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Pregabalin on Hyperalgesia and Post-operative Pain in Patients Undergoing Nephrectomy Surgery: Sex Differential Study
- ClinicalTrials.gov ID
- NCT02340455
- Acronym / sponsor ID
- 4-2014-0907
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: To rebalance the study plan because it is not desirable to set up comparators using placebo.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Jan 2015 (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.
Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA, an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting hyperalgesia. If the GABA level can be maintained at certain level, the progression into hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the effective postoperative pain management and the prevention of hyperalgesia from pregabalin, GABA analogue, and the possible sex difference in such effects of pregabalin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin_male | Experimental | Drug: Pregabalin_male |
| Pregabalin_female | Experimental | Drug: Pregabalin_female |
| Placebo_male | Active comparator | Drug: Placebo_Men |
| Placebo_female | Active comparator | Drug: Placebo_Women |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18, <51 years
Key exclusion criteria (8 listed)
- Female patients who are pregnant or menopause
- Patients undergoing hormonal therapy
- Patients having neurologic disease or already taking GABA related drugs (pregabalin, gabapentin), or taking opioid drugs
- Insulin resistant diabetes
- Renal deficiency (eGFR < 60 ml/min/1.73 m2)
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_malePregabalin 150mg bid 1day Men | Drug | Pregabalin_male |
| Pregabalin_femalePregabalin 150mg bid 1day Women | Drug | Pregabalin_female |
| Placebo_MenPlacebo durg | Drug | Placebo_male |
| Placebo_WomenPlacebo_Women | Drug | Placebo_female |
Primary outcome
Mechanical threshold
Time frame: from 1 day before op to postop 48 hr
Mechanical threshold can be measured using von Frey filaments at both incision site and non-dominant arm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin_male and Pregabalin_female in people with Living Kidney Donors Undergoing VAMS-nephrectomy, run by Yonsei University at 1 site in South Korea.
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 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: withdrawn, as of the sponsor's last update on 18 Feb 2019. 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 South Korea. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mechanical threshold (time frame: from 1 day before op to postop 48 hr). 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 18 Feb 2019.