Effect of Gabapentin on Pain of the Second Cataract Surgery

May 10, 2015 updated by: Hee-Pyoung Park, Seoul National University Hospital

The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Intra operative (pain while fluid injection to anterior chamber)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 10, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SerialCataractGaba

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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