NCT04345172

Lacrimal Dilator-Facilitated vs Standard Sub-Tenon's Block

Completed NA Last updated 14 April 2020

What this trial tests

NA trial testing sub-Tenon's block with a lacrimal dilator group or a Wescott scissors in to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors in 64 participants. Completed in 15 October 2019.

Timeline

1 January 2019

Primary endpoint
30 September 2019

15 October 2019

Quick facts

Lead sponsor	Baskent University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	64
Start date	1 January 2019
Primary completion	30 September 2019
Estimated completion	15 October 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• sub-Tenon's block with a lacrimal dilator group or a Wescott scissors

Conditions studied

• to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors — all drugs for to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors →

Sponsor

Baskent University

Who can join

Adults 20 to 90, any sex, with to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Standard sub-Tenon's block involves incision (dissection) of conjunctiva and Tenon's capsule with the help of blunt scissors and forceps, insertion of a blunt sub-Tenon's cannula under the Tenon's capsule and injection of local anaesthetic agent. This block is frequently associated with minor complications such as chemosis and subconjunctival haemorrhage. Different variations of incisionless sub-Tenon's block including the use of lacrimal dilator have been described to reduce minor complications and facilitate insertion of blunt cannula. Lacrimal dilator creates a small aperture in the conjunctiva and Tenon's capsule thus avoids incision. After ethics approval, patients undergoing elective cataract surgery were enrolled to receive sub-Tenon's block performed without incision with a lacrimal dilator (Group LD) or with incision using Wescott scissors and blunt forceps (Group WS). All patients received 3 mL 2% lidocaine without any adjuvant. No sedation was administered. Demographic of the patients, duration of the procedure, analgesia (pain), akinesia, duration of the procedure intraoperative chemosis, subconjunctival haemorrhage on the first postoperative day. We aimed to compare lacrimal dilator-facilitated and standard sub-Tenon's block effectiveness and incidence of chemosis and subconjunctival haemorrhage.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lacrimal dilator-facilitated incisionless vs. standard sub-Tenon's block: a randomized, prospective and non-inferiority comparative study.
   Coban-Karatas M, Cok OY, Kumar CM. · · 2021 · cited 1× · PMID 33005046 · DOI 10.1038/s41433-020-01207-0