Effect of Gabapentin on Pain of the Second Cataract Surgery

Phase 4

• Conditions: Hyperalgesia
• Interventions: Drug: placebo; Drug: gabapentin

• Registration Number: NCT02127853
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Status Verified: 2014-04
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Study Start: 2014-07
• Last Update Submitted: 2015-05-10
• Last Update Posted: 2015-05-12
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo drug pretreatment
Gabapentin	gabapentin	gabapentin pretreatment

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of