Effect of Gabapentin on Pain of the Second Cataract Surgery
The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery
1 other identifier
interventional
70
1 country
1
Brief Summary
Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 12, 2015
April 1, 2014
1.6 years
April 29, 2014
May 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of subjects who answer that "pain was greater" in the second eye surgery
Intra operative (pain while fluid injection to anterior chamber)
Secondary Outcomes (1)
perioperative pain
end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day
Other Outcomes (2)
satisfaction
intra operative
anxiety
baseline (at OR room arrival, just before sterile draping)
Study Arms (2)
Gabapentin
EXPERIMENTALgabapentin pretreatment
Placebo
PLACEBO COMPARATORplacebo drug pretreatment
Interventions
100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery
the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-799, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 1, 2014
Study Start
July 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 12, 2015
Record last verified: 2014-04