Clinical Trials Logo
  1. Home
  2. Anesthesia, Local
  3. NCT03871062
  4. Details
NCT03871062 Clinical Trial

Study of Two-step Anesthesia in Intravitreal Injection

Anesthesia, Local Clinical Trial

— TAIVI  

Official title:
A Prospective, Randomised, Single-masked Comparison of Topical Anesthesia and Topical Combined Subconjunctival (Two-step) Anesthesia in Intravitreal Injection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03871062
Other study ID # SHIRB20190228
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2019
Est. completion date January 1, 2020

Study information
Verified date March 2019
Source Aier School of Ophthalmology, Central South University
Contact Dong Lin
Phone +86-13080707858
Email lindong_1219@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) for intravitreal injection #TAIVI# vs topical anesthesia

Description:

Purpose: Patient pain for intravitreal injection is evaluated between topical anesthesia combined sub-conjunctival anesthesia (two-step anesthesia) and topical anesthesia.

Methods: This prospective, randomized, single-blinded clinical trail is conducted at Shanghai Aier Eye Hospital. Selected group of 60 patients will be randomized divided into 2 groups and underwent intravitreal injection of antiangiogenic agents and steroids. Group1 uses two-step anesthesia , whereas Group 2 uses topical anesthesia. A 5-point Visual Analogue Pain Scale is used to assess patients' pain score and surgeon's ease while operating. Any complications therefore will be made note of.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date January 1, 2020
Est. primary completion date September 11, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 85 Years
Eligibility Inclusion Criteria:

Neovascular age-related macular degeneration (wAMD); Pathologic myopia with choroidal neovascularisation (PM-CNV); Diabetic macular edema (DME); Retinal vein occlusion with macular edema (RVO-ME); Other diseases: uveitis with macular edema or choroidal neovascularisation.

Exclusion Criteria:

Communication problems; Allergy to amide-type local anaesthetic agents; History of vitreoretinal surgery or orbital surgery; Orbital deformity; With episcleral adjunct surgery; Trauma; Keratitis; Conjunctivitis.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Two step anesthesia
conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection
• topical anesthesia
conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times

Locations
Country Name City State
China Shanghai Aier Eye Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

Nguyen NCI, Fabro F, Ambresin A, Ezziat S, Bergin C, Mazzocato C, Mantel I. Factors associated with pain during intravitreal injection of anti-vascular endothelial growth factor. Eye (Lond). 2018 Sep;32(9):1544-1546. doi: 10.1038/s41433-018-0126-z. Epub 2 — View Citation

Sanabria MR, Montero JA, Losada MV, Fernández-Muñoz M, Galindo A, Fernández I, Coco RM, Sampedro A. Ocular pain after intravitreal injection. Curr Eye Res. 2013 Feb;38(2):278-82. doi: 10.3109/02713683.2012.758290. Epub 2013 Jan 18. — View Citation

Shin SH, Park SP, Kim YK. Factors Associated with Pain Following Intravitreal Injections. Korean J Ophthalmol. 2018 Jun;32(3):196-203. doi: 10.3341/kjo.2017.0081. Epub 2018 May 15. — View Citation

Shiroma HF, Takaschima AKK, Farah ME, Höfling-Lima AL, de Luca Canto G, Benedetti RH, Rodrigues EB. Patient pain during intravitreal injections under topical anesthesia: a systematic review. Int J Retina Vitreous. 2017 Jul 3;3:23. doi: 10.1186/s40942-017- — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain scores 5-point Visual Analogue Pain Scale (VAPS): Grade 1: No pain or discomfort; Grade 2: mild pain or discomfort; Grade 3: moderate pain or discomfort; Grade 4: severe pain or discomfort During surgery
Secondary Surgeon's ease Grade 1: No discomfort; Grade 2: mild discomfort; Grade 3: moderate discomfort; Grade 4: severe discomfort During surgery
See also
  Status Clinical Trial Phase
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04513652 - A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution Phase 3
Completed NCT05464862 - The Effect of PPB Using 10, 20 and 30 ml of Lidocaine, Study on Volunteers Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT03245359 - Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks N/A
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Not yet recruiting NCT05815563 - Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics
Completed NCT01418690 - Changes in Tissue Oxygenation Following Regional Anesthesia N/A
Suspended NCT03291691 - Protective Nerve Stimulation in Regional Anesthesia
Not yet recruiting NCT03545516 - Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery Phase 2
Not yet recruiting NCT05038007 - Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades Phase 2
Terminated NCT03672500 - Perineal Local Infiltration Study N/A
Enrolling by invitation NCT06057090 - Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients? N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Recruiting NCT06011005 - Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel. N/A
Completed NCT04536311 - Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block N/A
Completed NCT03600454 - The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response N/A
Recruiting NCT03159338 - Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy N/A
Completed NCT02966067 - A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4