NCT03577574

Brief Summary

A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia(two-step anesthesia) for minimally invasive vitrectomy（TAMIV）vs peribulbar block vs retrobulbar block

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 5, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

May 28, 2018

Last Update Submit

July 2, 2018

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • surgeon's ease

    During surgery

Study Arms (3)

retrobulbar anesthesia group

ACTIVE COMPARATOR

2% lidocaine 4ml injected into retrobulbar space

Procedure: retrobulbar anesthesia

peribulbar anesthesia group

ACTIVE COMPARATOR

2% lidocaine 4 to 8ml injected into peribulbar space

Procedure: peribulbar anesthesia

two step anesthesia group

EXPERIMENTAL

conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection

Procedure: two step anesthesia

Interventions

retrobulbar anesthesiaPROCEDURE

2% lidocaine 4ml injected into retrobulbar space

retrobulbar anesthesia group
peribulbar anesthesiaPROCEDURE

2% lidocaine 4 to 8ml injected into peribulbar space

peribulbar anesthesia group
two step anesthesiaPROCEDURE

conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection

two step anesthesia group

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Proliferative diabetic retinopathy (PDR);
  • Vitreous haemorrhage (VH);
  • Retinal detachment (RD);
  • Retinal vein occlusion(RVO);
  • Other diseases (idiopathic macular hole, macular pucker and high myopic maculopathy);
  • Silicone oil-filled eye.

You may not qualify if:

  • 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 and active uveitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wensheng Li

Shanghai, China

RECRUITING

Related Publications (4)

  • Chan WM, Loo AV, Tam BS. Topical anesthesia in posterior vitrectomy. Retina. 2000;20(5):563-5. doi: 10.1097/00006982-200005000-00029. No abstract available.

    PMID: 11039443BACKGROUND

  • Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.

    PMID: 17392852BACKGROUND

  • Schrader WF, Schargus M, Schneider E, Josifova T. Risks and sequelae of scleral perforation during peribulbar or retrobulbar anesthesia. J Cataract Refract Surg. 2010 Jun;36(6):885-9. doi: 10.1016/j.jcrs.2009.12.029.

    PMID: 20494757BACKGROUND

  • Takaschima A, Marchioro P, Sakae TM, Porporatti AL, Mezzomo LA, De Luca Canto G. Risk of Hemorrhage during Needle-Based Ophthalmic Regional Anesthesia in Patients Taking Antithrombotics: A Systematic Review. PLoS One. 2016 Jan 22;11(1):e0147227. doi: 10.1371/journal.pone.0147227. eCollection 2016.

    PMID: 26800356BACKGROUND

Study Officials

  • Wensheng Li

    Shanghai Aier Eye Hosptial

    STUDY DIRECTOR

Central Study Contacts

Hua Fan

CONTACT

+8618988761617fanhua1116@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

July 5, 2018

Study Start

August 2, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

July 5, 2018

Record last verified: 2018-05

Locations

CN(1)