Effect of Gabapentin on Pain of the Second Cataract Surgery

Hyperalgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02127853
• Other study ID #: SerialCataractGaba
• Status: Recruiting
• Phase: Phase 4
• First received: April 29, 2014
• Last updated: May 10, 2015
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2014
• Source: Seoul National University Hospital
• Contact: Heepyoung Park, MD,PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Hyperalgesia

Intervention

Drug:
• gabapentin
100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery
• placebo
the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	satisfaction	evaluation of satisfaction of both operator and patient	intra operative	No
Other	anxiety	evaluation of patient's anxiety	baseline (at OR room arrival, just before sterile draping)	No
Primary	proportion of subjects who answer that "pain was greater" in the second eye surgery		Intra operative (pain while fluid injection to anterior chamber)	No
Secondary	perioperative pain	evaluation of overall perioperative pain	end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day	No