Clinical Trial: Saline Injection - Assisted Anesthesia in Eyelid Surgery
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Saline Injection - Assisted Anesthesia in Eyelid Surgery
Brief Summary: The investigators hypothesize that injection of saline to the upper eyelids prior to lidocaine/adrenaline injection will reduce pain of the local anesthetic in comparison to injection of lidocaine alone.
Detailed Summary:
Purpose:
To carry out a prospective randomised controlled clinical trial to compare the efficacy of saline injection prior to the injection of Lidocaine/Adrenaline in reducing the pain of local anaesthetic injections into the upper eyelid.
Hypothesis:
Injection of saline to the upper eyelids prior to lidocaine/adrenaline injection reduces the pain of anaesthetic injections in upper eyelid surgery.
Justification:
In many surgical procedures performed under local anaesthetic, the most frightening and painful aspect of the procedure for patients is the anaesthetic injection, and various techniques have been advocated to address this.
Simple measures that reduce the pain of anaesthetic injection and are widely practised include administering the injection slowly and using a fine-bore needle (30 Gauge). Other techniques that have been shown to be effective include warming or buffering the local anaesthetic. The use of 0.9% bacteriostatic saline solution in conjunction with lidocaine has been demonstrated to significantly reduce patients' perceived pain during the injection and operative procedure in eyelid surgery. Cooling the skin immediately prior to treatment has been shown to reduce the pain of dermatological laser procedures although this might be difficult to perform around the eyes because of the risk of injuring the cornea. Similarly, topical anaesthetic agents, such as EMLA (eutectic mixture of local anaesthetics) cream, which are applied to the skin one hour prior to injection are commonly employed for use on the limbs of infants and children but are not safe for use around the eyes since inadvertent ocular application ca
Sponsor: Sheba Medical Center
Current Primary Outcome: Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow [ Time Frame: 1-2 minutes ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sheba Medical Center
Dates:
Date Received: November 2, 2010
Date Started: November 2010
Date Completion: December 2011
Last Updated: August 7, 2011
Last Verified: August 2011
