Comparison of Three Different Anesthetic Approaches for Intravitreal Injections

NCT02263690 | Completed Phase 4 DMC

• 1 other identifier: RetinaC
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups: proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival lidocaine (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their pain experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately following the injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients also graded the overall injection experience as Excellent, Very Good, Fair, Poor or Awful. The physician evaluated the patient's eye movement during intravitreal injection in three levels: none or minimal (0), not compromising the injection (1), compromising the injection (2).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain experience and patient satisfaction after 3 different anesthetic approaches for intravitreal injections

  Pain experience according the visual analogue scale (VAS), a scale of 0 to 10 (0 = no pain, 10 = worst pain ever). Patient satisfaction according the overall injection experience, graded by the patient as Excellent, Very Good, Fair, Poor, or Awful.

  immediately after injection, 10 minutes, 1 hour, 6 hours and 24 hours later

Study Arms (3)

Group Drops

ACTIVE COMPARATOR

proparacaine 0.5% drops (Group Drops) Patients from group Drops received a drop of proparacaine 0.5% before receiving a drop of povidone iodine 5%. Patients from Group Drops received a second drop of proparacaine 0.5%, 5 minutes after the drop of povidone iodine 5%.

Procedure: Group Drops

Group SC

ACTIVE COMPARATOR

proparacaine 0.5% drops plus subconjunctival lidocaine (Group SC) Patients from group SC received a drop of proparacaine 0.5% before receiving a drop of povidone iodine 5%. For the patients from Group SC, a subconjunctival bleb of anesthesia was created by injecting 0.4 ml of lidocaine 1% into the subconjunctival space, posteriorly to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-ml syringe.

Procedure: Group SC

Group Gel

ACTIVE COMPARATOR

Lidocaine gel 2% on the eye (Group Gel) Patients from Group Gel received 1 mL of 2% lidocaine gel on the eye before receiving the drop of povidone iodine 5%. For the patients from Group Gel, 1 mL of 2% lidocaine gel was applied on the eye before receiving the drop of povidone iodine 5%.

Procedure: Group gel

Interventions

Group Drops PROCEDURE

The patients in the group Drops received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. The patients in the group Drops received a second drop of proparacaine 0.5% 5 minutes after the drop of povidone iodide 5%

Also known as: Proparacaine 0.5% drops

Group Drops

Group SC PROCEDURE

The patients in the group SC received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. In the patients in the group SC, a subconjunctival bleb of anesthesia was created by injecting 0,4 mL of lidocaine 1% into the subconjunctival space 4 mm posterior to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-mL syringe.

Also known as: Subconjunctival 1% Lidocaine

Group SC

Group gel PROCEDURE

For the patients in group gel, the gel was placed on the eye before receiving the peri-ocular drop of povidone iodide 5%.

Also known as: Lidocaine 2% gel

Group Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older
• Indications for injection included neovascular AMD, DME and cystoid macular edema (CME) secondary to RVO.

You may not qualify if:

• Previous known allergic response to the topical anesthetics to be used.
• Previous intravitreal injections of drugs other than anti-VEGF agents
• Previous pars plana vitrectomy
• Anterior segment conditions that could affect pain sensation, such as conjunctival irritation, active conjunctivitis or keratitis or bullous keratopathy
• Patients using systemic analgesic or sedative medications

Sponsors & Collaborators

• Retina Clinic, Sao Paulo, Brazil: lead

Study Sites (1)

Retina Clinic

Osasco, São Paulo, 06010-130, Brazil

Location

Related Publications (16)

• Aiello LP, Brucker AJ, Chang S, Cunningham ET Jr, D'Amico DJ, Flynn HW Jr, Grillone LR, Hutcherson S, Liebmann JM, O'Brien TP, Scott IU, Spaide RF, Ta C, Trese MT. Evolving guidelines for intravitreous injections. Retina. 2004 Oct;24(5 Suppl):S3-19. doi: 10.1097/00006982-200410001-00002.

  PMID: 15483476 RESULT

• Ulrich JN. Topical nepafenac after intravitreal injection: a prospective double-masked randomized controlled trial. Retina. 2014 Mar;34(3):509-11. doi: 10.1097/IAE.0b013e3182a0e611.

  PMID: 23928675 RESULT

• Brynskov T, Kemp H, Sorensen TL. No cases of endophthalmitis after 20,293 intravitreal injections in an operating room setting. Retina. 2014 May;34(5):951-7. doi: 10.1097/IAE.0000000000000071.

  PMID: 24317292 RESULT

• Nuzzi R, Tridico F. Local and systemic complications after intravitreal administration of anti-vascular endothelial growth factor agents in the treatment of different ocular diseases: a five-year retrospective study. Semin Ophthalmol. 2015 Mar;30(2):129-35. doi: 10.3109/08820538.2013.835833. Epub 2013 Oct 30.

  PMID: 24171832 RESULT

• Cintra LP, Lucena LR, Da Silva JA, Costa RA, Scott IU, Jorge R. Comparative study of analgesic effectiveness using three different anesthetic techniques for intravitreal injection of bevacizumab. Ophthalmic Surg Lasers Imaging. 2009 Jan-Feb;40(1):13-8. doi: 10.3928/15428877-20090101-05.

  PMID: 19205490 RESULT

• Kaderli B, Avci R. Comparison of topical and subconjunctival anesthesia in intravitreal injection administrations. Eur J Ophthalmol. 2006 Sep-Oct;16(5):718-21. doi: 10.1177/112067210601600509.

  PMID: 17061223 RESULT

• Bartfield JM, Holmes TJ, Raccio-Robak N. A comparison of proparacaine and tetracaine eye anesthetics. Acad Emerg Med. 1994 Jul-Aug;1(4):364-7. doi: 10.1111/j.1553-2712.1994.tb02646.x.

  PMID: 7614283 RESULT

• Blaha GR, Tilton EP, Barouch FC, Marx JL. Randomized trial of anesthetic methods for intravitreal injections. Retina. 2011 Mar;31(3):535-9. doi: 10.1097/IAE.0b013e3181eac724.

  PMID: 21102369 RESULT

• Davis MJ, Pollack JS, Shott S. Comparison of topical anesthetics for intravitreal injections : a randomized clinical trial. Retina. 2012 Apr;32(4):701-5. doi: 10.1097/IAE.0b013e31822f27ca.

  PMID: 22282296 RESULT

• Kozak I, Cheng L, Freeman WR. Lidocaine gel anesthesia for intravitreal drug administration. Retina. 2005 Dec;25(8):994-8. doi: 10.1097/00006982-200512000-00007.

  PMID: 16340529 RESULT

• Friedman SM, Margo CE. Topical gel vs subconjunctival lidocaine for intravitreous injection: a randomized clinical trial. Am J Ophthalmol. 2006 Nov;142(5):887-8. doi: 10.1016/j.ajo.2006.06.033.

  PMID: 17056383 RESULT

• Page MA, Fraunfelder FW. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601-9. doi: 10.2147/opth.s4935. Epub 2009 Nov 2.

  PMID: 19898665 RESULT

• Boden JH, Myers ML, Lee T, Bushley DM, Torres MF. Effect of lidocaine gel on povidone-iodine antisepsis and microbial survival. J Cataract Refract Surg. 2008 Oct;34(10):1773-5. doi: 10.1016/j.jcrs.2008.05.056.

  PMID: 18812132 RESULT

• Inman ZD, Anderson NG. Incidence of endophthalmitis after intravitreal injection of antivascular endothelial growth factor medications using topical lidocaine gel anesthesia. Retina. 2011 Apr;31(4):669-72. doi: 10.1097/IAE.0b013e3181ef463d.

  PMID: 21178659 RESULT

• Charles S, Rosenfeld PJ, Gayer S. Medical consequences of stopping anticoagulant therapy before intraocular surgery or intravitreal injections. Retina. 2007 Sep;27(7):813-5. doi: 10.1097/IAE.0b013e318154b9f2. No abstract available.

  PMID: 17891002 RESULT

• Meyer CH, Callizo J, Mennel S, Kussin A. Perioperative management of anticoagulated patients undergoing repeated intravitreal injections. Arch Ophthalmol. 2007 Jul;125(7):994. doi: 10.1001/archopht.125.7.994. No abstract available.

  PMID: 17620596 RESULT

MeSH Terms

Conditions

Pain

Interventions

proxymetacaine; Lidocaine; Gels

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Gabriel C Andrade, M.D.

  Vitreo-retinal Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gabriel Costa de Andrade

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 13, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

BR (1)