Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia

August 15, 2011 updated by: Isfahan University of Medical Sciences
The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of, 7864329800
        • Recruiting
        • Isfahan University of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Amin Masjedi, MD

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 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Retinal detachment
  • Retinal tear less than 3 hour clock

Exclusion Criteria:

  • Vitreous hemorrhage
  • Proliferative vitreoretinopathy

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lidocaine
Drug: lidocaine
to evaluate the effect of lidocaine on oculocardiac reflex during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraoperative heart rate measurement
Time Frame: 6 month
6 month
decrease in pain and nausea,vomiting after surgery
Time Frame: 6 month
6 month
decrease in ocr after application of topical lidocaine
Time Frame: 6 month
6 month
postoperative nausea and vommitting
Time Frame: 6 month
6 month
postoperative pain
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

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

January 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (ESTIMATE)

August 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199

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.

Subscribe