Saline Injection - Assisted Anesthesia in Eyelid Surgery

Blepharoptosis Clinical Trial

Official title:

Saline Injection - Assisted Anesthesia in Eyelid Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01239498
• Other study ID #: SHEBA-10-8246-DF-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: November 2, 2010
• Last updated: August 7, 2011
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: Sheba Medical Center
• Contact: Ido Didi Fabian, MD
• Phone: +972547830444
• Email: didifabian[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharoptosis

Intervention

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%
• Lidocaine/Adrenaline only
Injection of Lidocaine/Adrenaline only

Locations

Country	Name	City	State
Israel	Goldschlager eye institute	Ramat Gan
Israel	Goldschleger institute of ophthalmology, Sheba medical center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Bainbridge LC. Comparison of room temperature and body temperature local anaesthetic solutions. Br J Plast Surg. 1991 Feb-Mar;44(2):147-8. — View 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. — View 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. — View Citation

Chen BK, Eichenfield LF. Pediatric anesthesia in dermatologic surgery: when hand-holding is not enough. Dermatol Surg. 2001 Dec;27(12):1010-8. Review. — View 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. — View Citation

Stewart JH, Cole GW, Klein JA. Neutralized lidocaine with epinephrine for local anesthesia. J Dermatol Surg Oncol. 1989 Oct;15(10):1081-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow		1-2 minutes	No