Effect of Gabapentin on Pain of the Second Cataract Surgery

NCT ID: NCT02127853

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-02-29

Brief Summary

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Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery.

Detailed Description

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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

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Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Gabapentin

gabapentin pretreatment

Group Type EXPERIMENTAL

gabapentin

Intervention Type DRUG

100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery

Placebo

placebo drug pretreatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery

Interventions

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gabapentin

100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery

Intervention Type DRUG

placebo

the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Pyoung Park

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Heepyoung Park, MD,PhD

Role: CONTACT

82-2-2072-2466

Eugene Kim, MD

Role: CONTACT

82-2-2072-2469

Facility Contacts

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Heepyoung Park, MD, PhD

Role: primary

82-2-2072-2466

Eugene Kim, MD

Role: backup

82-2-2072-2469

Other Identifiers

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SerialCataractGaba

Identifier Type: -

Identifier Source: org_study_id

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