Effect of Gabapentin on Pain of the Second Cataract Surgery | NCT02127853

Studies
Effect of Gabapentin on Pain of the Second Cataract Surgery

NCT02127853

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

May 12, 2015Estimated

Enrollment

70Estimated

Phase

Phase 4

Conditions

Hyperalgesia

Interventions

gabapentin
placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Feb 2016Estimated

Completion Date

Feb 2016Estimated

First Submitted Date

Apr 29, 2014

First Submission Date that Met QC Criteria

Apr 30, 2014

First Posted Date

May 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2015

Last Update Posted Date

May 12, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hee-Pyoung Park, associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin	Experimental	gabapentin pretreatment	Drug: gabapentin
Placebo	Placebo Comparator	placebo drug pretreatment	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gabapentin	Drug	100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery	Gabapentin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
perioperative pain	evaluation of overall perioperative pain	end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day

Other Outcomes

Measure	Description	Time Frame
satisfaction	evaluation of satisfaction of both operator and patient	intra operative
anxiety	evaluation of patient's anxiety	baseline (at OR room arrival, just before sterile draping)

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heepyoung Park, MD,PhD	Contact	82-2-2072-2466		hppark@snu.ac.kr
Eugene Kim, MD	Contact	82-2-2072-2469		tomomie@hanmail.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-799	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006930	Hyperalgesia

Ancestor Terms

ID	Term
D020886	Somatosensory Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided