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

NCT04345172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-04-14

No results posted yet for this study

Summary

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.

Conditions

  • to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors

Interventions

DEVICE

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

Local anaesthetic eye drops were installed into the conjunctiva, followed by iodine 5% aqueous drops to the conjunctival sac for 3 minutes.19 An eye lid speculum was inserted. In group LD, the conjunctiva and Tenon's capsule were lifted together tightly with a blunt forceps like a tent in the inferonasal quadrant and a punctal dilatator (Castroviejo Lacrimal Dilatator, Katena Products, Inc, Denville, NJ, USA) was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus (Fig.1). The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula (Visitec, Beaver-Visitec International Ltd, Warwickshire, UK). In Group WS, after lifting the conjunctiva and Tenon's capsule together with a blunt forceps, incision was performed with a blunt tip Westcott scissors in the inferonasal conjunctival at 5 mm posterior to limbus to expose sub-Tenon's space.

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-09-30
Completion
2019-10-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345172 on ClinicalTrials.gov