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Effect of Gabapentin on Pain of the Second Cataract Surgery

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ClinicalTrials.gov Identifier: NCT02127853
Recruitment Status : Unknown
Verified April 2014 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Study Description
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Brief Summary:
Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery.

Condition or disease Intervention/treatment Phase
Hyperalgesia Drug: gabapentin Drug: placebo Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery
Study Start Date : July 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gabapentin
gabapentin pretreatment
 Drug: gabapentin
100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery
Placebo Comparator: Placebo
placebo drug pretreatment
 Drug: placebo
the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. perioperative pain [ Time Frame: end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day ]
    evaluation of overall perioperative pain


Other Outcome Measures:
  1. satisfaction [ Time Frame: intra operative ]
    evaluation of satisfaction of both operator and patient

  2. anxiety [ Time Frame: baseline (at OR room arrival, just before sterile draping) ]
    evaluation of patient's anxiety


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127853


Contacts
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Contact: Heepyoung Park, MD,PhD 82-2-2072-2466 hppark@snu.ac.kr
Contact: Eugene Kim, MD 82-2-2072-2469 tomomie@hanmail.net

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-799
Contact: Heepyoung Park, MD, PhD    82-2-2072-2466    hppark@snu.ac.kr   
Contact: Eugene Kim, MD    82-2-2072-2469    tomomie@hanmail.net   
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Hee-Pyoung Park, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02127853    
Other Study ID Numbers: SerialCataractGaba
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: April 2014
Keywords provided by Hee-Pyoung Park, Seoul National University Hospital:
serial cataract surgery
hyperalgesia
gabapentin
central sensitization
Additional relevant MeSH terms:
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Hyperalgesia
Cataract
Lens Diseases
Eye Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents