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Saline Injection - Assisted Anesthesia in Eyelid Surgery

Primary Purpose

Blepharoptosis

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Injection of Saline + Lidocaine/Adrenaline
Lidocaine/Adrenaline only
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharoptosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Goldschlager eye instituteRecruiting
  • Goldschleger institute of ophthalmology, Sheba medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Saline + Lidocaine/Adrenaline

Lidocaine/Adrenaline only

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 2, 2010
Last Updated
August 7, 2011
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01239498
Brief Title
Saline Injection - Assisted Anesthesia in Eyelid Surgery
Official Title
Saline Injection - Assisted Anesthesia in Eyelid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline + Lidocaine/Adrenaline
Arm Type
Experimental
Arm Title
Lidocaine/Adrenaline only
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Injection of Saline + Lidocaine/Adrenaline
Other Intervention Name(s)
Local eyelid anesthesia
Intervention Description
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%
Intervention Type
Procedure
Intervention Name(s)
Lidocaine/Adrenaline only
Other Intervention Name(s)
Local eyelid anesthesia
Intervention Description
Injection of Lidocaine/Adrenaline only
Primary Outcome Measure Information:
Title
Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow
Time Frame
1-2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ido Didi Fabian, MD
Phone
+972547830444
Email
didifabian@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ido Didi Fabian, MD
Organizational Affiliation
Sheba medical center, Goldschleger institute
Official's Role
Study Chair
Facility Information:
Facility Name
Goldschlager eye institute
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ido Ido Fabian, MD
Email
didifabian@gmail.com
Facility Name
Goldschleger institute of ophthalmology, Sheba medical center
City
Ramat Gan
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ido Didi Fabian, MD
Phone
+972547830444
Email
didifabian@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
11849262
Citation
Chen BK, Eichenfield LF. Pediatric anesthesia in dermatologic surgery: when hand-holding is not enough. Dermatol Surg. 2001 Dec;27(12):1010-8. doi: 10.1046/j.1524-4725.2001.01854.x.
Results Reference
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PubMed Identifier
7618771
Citation
Brogan GX Jr, Giarrusso E, Hollander JE, Cassara G, Maranga MC, Thode HC. Comparison of plain, warmed, and buffered lidocaine for anesthesia of traumatic wounds. Ann Emerg Med. 1995 Aug;26(2):121-5. doi: 10.1016/s0196-0644(95)70139-7.
Results Reference
background
PubMed Identifier
2018901
Citation
Bainbridge LC. Comparison of room temperature and body temperature local anaesthetic solutions. Br J Plast Surg. 1991 Feb-Mar;44(2):147-8. doi: 10.1016/0007-1226(91)90050-t.
Results Reference
background
PubMed Identifier
2794204
Citation
Stewart JH, Cole GW, Klein JA. Neutralized lidocaine with epinephrine for local anesthesia. J Dermatol Surg Oncol. 1989 Oct;15(10):1081-3. doi: 10.1111/j.1524-4725.1989.tb03127.x.
Results Reference
background
PubMed Identifier
2240750
Citation
Bartfield JM, Gennis P, Barbera J, Breuer B, Gallagher EJ. Buffered versus plain lidocaine as a local anesthetic for simple laceration repair. Ann Emerg Med. 1990 Dec;19(12):1387-9. doi: 10.1016/s0196-0644(05)82603-4.
Results Reference
background
PubMed Identifier
20303597
Citation
Fayers T, Morris DS, Dolman PJ. Vibration-assisted anesthesia in eyelid surgery. Ophthalmology. 2010 Jul;117(7):1453-7. doi: 10.1016/j.ophtha.2009.11.025. Epub 2010 Mar 19.
Results Reference
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Saline Injection - Assisted Anesthesia in Eyelid Surgery

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