Saline Injection - Assisted Anesthesia in Eyelid Surgery

August 7, 2011 updated by: Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 causes corneal de-epithelisation.

Sedative agents, such as midazolam may be useful in anxious patients, but this requires the input of an anaesthetist and it is often difficult to finely control the level of sedation; it is usually preferable not to have patients sedated during eyelid surgery when patient cooperation is required intra-operatively to assess the height of the eyelids, for example in ptosis surgery.

The investigators have noticed in clinical practice that whenever the investigators injected saline into the upper eyelids prior to the injection of the mixture of lidocaine/adrenaline the patients reported of no pain. The investigators assume that by using the isotonic saline cells in the tissue are not harmed and a minor effect of anesthesia is achieved. The anesthetic solution injected later on is diluted, however the eyelid is properly anesthesized.

Research Methods:

The study will be a prospective, interventional, randomised, controlled clinical trial.

All patients who fit the inclusion criteria will be offered participation in the trial on the day their surgery is booked. They will be given an information leaflet about the trial, explaining the aim of the study without describing the effect of the saline injection prior to the anesthetic solution injection in order to reduce the risk of biasing their perception. They will be advised that non-participation will not affect their care in anyway.

The intervention is of no risk to the patient and will not affect the surgical procedure in any way. Any questions that the patient has will be addressed beforehand and they will be required to sign a consent form prior to inclusion in the trial.

They will be advised beforehand that they will be required to verbally rate their pain score on a scale of 0 to 10 immediately after both sides have been anaesthetised, with 0 being no pain and 10 being the worst imaginable pain.

All participants included in the study will undergo bilateral surgery and will therefore act as their own controls: Saline will only be injected prior to the injection of the anaesthetic into one side. The test and placebo will be randomly assigned to either the first or second eyelid; the right eyelid will be injected first in all patients, as is routine practice. Computer-generated sequential binary randomisation will be used. Allocation will be concealed from the surgeon until immediately prior to the anaesthetic injection.

All anaesthetic injections will consist of xylocaine 1% with 1:100,000 adrenaline and will be administered through a short 30 Gauge needle at a constant slow speed at multiple (6-7) sites along the upper lid by a single oculoplastic consultant.

Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow.

Planned sample size On a scale of 0 to 10 a difference in pain score of 1.5 may be considered to be clinically significant. The power calculation for a paired t-test with 90% power and p=0.05 demonstrated that a sample size of 80 patients to be more than sufficient to detect a significant difference.

The results will be submitted for publication in a peer-reviewed ophthalmological journal and presentation at international ophthalmological meetings.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

  • Israel
      • Ramat Gan, Israel
      • Ramat Gan, Israel
        • Not yet recruiting
        • Goldschleger institute of ophthalmology, Sheba medical center
        • Contact:

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing bilateral upper eyelid surgery under local anaesthetic who have given fully informed consent to be in the trial

Exclusion Criteria:

  • Previous upper eyelid surgery

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saline + Lidocaine/Adrenaline
Procedure: Injection of Saline + Lidocaine/Adrenaline

All anaesthetic injections will consist of xylocaine 1% with 1:100,000 adrenaline and will be administered through a short 30 Gauge needle at a constant slow speed at multiple (6-7) sites along the upper lid by a single oculoplastic consultant.

The experimental eyelid will receive a saline-consisted injection 0.5cc prior to the administration of the anesthetic injection.

Injection of Saline + Lidocaine 1%

Other Names:
  • Local eyelid anesthesia
Placebo Comparator: Lidocaine/Adrenaline only
Procedure: Lidocaine/Adrenaline only
Injection of Lidocaine/Adrenaline only
Other Names:
  • Local eyelid anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow
Time Frame: 1-2 minutes
1-2 minutes

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Study Chair: Ido Didi Fabian, MD, Sheba medical center, Goldschleger institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 7, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-10-8246-DF-CTIL

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.

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