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Effect of Gabapentin on Pain of the Second Cataract Surgery

Primary Purpose

Hyperalgesia

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gabapentin
placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperalgesia focused on measuring serial cataract surgery, hyperalgesia, gabapentin, central sensitization

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

gabapentin pretreatment

placebo drug pretreatment

Outcomes

Primary Outcome Measures

proportion of subjects who answer that "pain was greater" in the second eye surgery

Secondary Outcome Measures

perioperative pain
evaluation of overall perioperative pain

Full Information

First Posted
April 29, 2014
Last Updated
May 10, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02127853
Brief Title
Effect of Gabapentin on Pain of the Second Cataract Surgery
Official Title
The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
Keywords
serial cataract surgery, hyperalgesia, gabapentin, central sensitization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
gabapentin pretreatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo drug pretreatment
Intervention Type
Drug
Intervention Name(s)
gabapentin
Intervention Description
100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
perioperative pain
Description
evaluation of overall perioperative pain
Time Frame
end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day
Other Pre-specified Outcome Measures:
Title
satisfaction
Description
evaluation of satisfaction of both operator and patient
Time Frame
intra operative
Title
anxiety
Description
evaluation of patient's anxiety
Time Frame
baseline (at OR room arrival, just before sterile draping)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heepyoung Park, MD,PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Kim, MD
Phone
82-2-2072-2469
Email
tomomie@hanmail.net
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heepyoung Park, MD, PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD
Phone
82-2-2072-2469
Email
tomomie@hanmail.net

12. IPD Sharing Statement

Learn more about this trial

Effect of Gabapentin on Pain of the Second Cataract Surgery

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