Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia

Retinal Detachment Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417572
• Other study ID #: 199
• Status: Recruiting
• Phase: Phase 4
• First received: August 9, 2011
• Last updated: August 15, 2011
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2010
• Source: Isfahan University of Medical Sciences
• Contact: Amin Masjedi, MD
• Phone: +983112211915
• Email: Masjedi1827[@]gmail.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Retinal detachment

• Retinal tear less than 3 hour clock

Exclusion Criteria:

• Vitreous hemorrhage

• Proliferative vitreoretinopathy

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

• Retinal Detachment

Intervention

Drug:
• lidocaine
to evaluate the effect of lidocaine on oculocardiac reflex during the surgery

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative heart rate measurement		6 month	Yes
Primary	decrease in pain and nausea,vomiting after surgery		6 month	Yes
Primary	decrease in ocr after application of topical lidocaine		6 month	Yes
Primary	postoperative nausea and vommitting		6 month	Yes
Primary	postoperative pain		6 month	Yes