HyperalgesiaPhase 4NCT02127853
Effect of Gabapentin on Pain of the Second Cataract Surgery
A Phase 4 study testing gabapentin in people with Hyperalgesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Feb 2016
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient of ASA(American Cociety of Anesthesiology) class I, II, III between age 20 to 80, scheduled for serial bilateral cataract surgery(1 weel interval)
Who cannot join
- refuse to participate
- BMI<16 or BMI >30
- severe cardiovascular, pulmonary, renal disease
- alcohol or drug abuse
- currently taking CNS(central nervous system) inhibitory drugs
- taking antiacids
- depressive disorder pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-799
Heepyoung Park, MD, PhD, 82-2-2072-2466, hppark@snu.ac.kr
Eugene Kim, MD, 82-2-2072-2469, tomomie@hanmail.net
About this study
Official title: The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery
Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery.
Read the detailed description
Hyperalgesia occurring at the second operation in bilateral eye surgery is well known, and mechanism of central sensitization might be involved. Gabapentin is known to lower the effect of central sensitization, and its effect on acute postoperative pain has been reported. Therefore, pretreatment of gabapentin after first operation may reduce the pain at second operation.
- Conditions
- Hyperalgesia
- Being tested
- gabapentin, placebo
- Keywords
- serial cataract surgery, hyperalgesia, gabapentin, central sensitization
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery
placeboDrug
the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | gabapentin pretreatment Receives: Drug: gabapentin |
| Placebo | Placebo comparator | placebo drug pretreatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects who answer that "pain was greater" in the second eye surgery
Measured: Intra operative (pain while fluid injection to anterior chamber)
Secondary outcomes (1)
perioperative pain
evaluation of overall perioperative pain
Measured: end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- More trials run by Seoul National 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127853
- Sponsor's protocol ID
- SerialCataractGaba
- Status last verified
- Apr 2014
- First submitted
- 29 Apr 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT02127853
- Acronym / sponsor ID
- SerialCataractGaba
- Conditions
- Hyperalgesia
- Keywords
- serial cataract surgery, hyperalgesia, gabapentin, central sensitization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 1 May 2014 (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.
Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery.
Detailed description
Hyperalgesia occurring at the second operation in bilateral eye surgery is well known, and mechanism of central sensitization might be involved. Gabapentin is known to lower the effect of central sensitization, and its effect on acute postoperative pain has been reported. Therefore, pretreatment of gabapentin after first operation may reduce the pain at second operation.
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 |
|---|---|---|
| Gabapentin | Experimental | Drug: gabapentingabapentin pretreatment |
| Placebo | Placebo comparator | Drug: placeboplacebo drug pretreatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient of ASA(American Cociety of Anesthesiology) class I, II, III between age 20 to 80, scheduled for serial bilateral cataract surgery(1 weel interval)
Key exclusion criteria (7 listed)
- refuse to participate
- BMI<16 or BMI >30
- severe cardiovascular, pulmonary, renal disease
- alcohol or drug abuse
- currently taking CNS(central nervous system) inhibitory drugs
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 |
|---|---|---|
| gabapentin100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery | Drug | Gabapentin |
| placebothe same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery | Drug | Placebo |
Primary outcome
proportion of subjects who answer that "pain was greater" in the second eye surgery
Time frame: Intra operative (pain while fluid injection to anterior chamber)
1 secondary outcome
perioperative pain
Time frame: end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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.
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 gabapentin in people with Hyperalgesia, run by Seoul National University Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 12 May 2015. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heepyoung Park, MD,PhD (82-2-2072-2466, hppark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of subjects who answer that "pain was greater" in the second eye surgery (time frame: Intra operative (pain while fluid injection to anterior chamber)). 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 May 2015.