Effect of Gabapentin on Pain of the Second Cataract Surgery

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02127853

Collaborator

(none)

Enrollment

Location

Arms

19.1

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2016

Anticipated Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Primary Outcome Measures

proportion of subjects who answer that "pain was greater" in the second eye surgery [Intra operative (pain while fluid injection to anterior chamber)]

Secondary Outcome Measures

perioperative pain [end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day]
evaluation of overall perioperative pain

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)