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

NCT ID: NCT04345172

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-10-15

Brief 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.

Detailed Description

The patients were randomly allocated to receive STB performed with a lacrimal dilator (Group LD) and with a Wescott scissors (Group WS). Randomization was ensured by sealed envelopes prepared according to a computer-generated table and the envelopes were opened by the operator just before the sub-Tenon's block.

Study protocol 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 was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus. The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula .

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. The block was performed with the above sub-Tenon's cannula.

All patients received lidocaine 2%, 3 mL without any adjuvant. No sedative was administered. All the blocks and surgeries were performed by the same investigator, but block evaluations were made by another investigator who was blinded to the technique used. All patients were discharged on the day of surgery.

The parameters recorded included demographic of the patients, duration of the procedure, analgesia (pain), akinesia, duration of the procedure intraoperative chemosis, subconjunctival haemorrhage on the first postoperative day. Analgesia was evaluated using a numeric rating scale for pain (0-10; 0 - no pain, 10 - the worst imaginable pain) immediately after the operation. Akinesia (ocular movements) were checked according to 4-primary gazes 10 minutes after STB. Chemosis and conjunctival haemorrhage (1st postoperative day) were assessed according to the number of quadrant or quadrants affected (superior nasal, superior temporal, inferior nasal, inferior temporal) using a 5-point scale (0-4; 0 - no for chemosis and haemorrhage, 4 for chemosis or haemorrhage in all 4 quadrants).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

a lacrimal dilator group (Group LD)

The patients allocated to receive STB performed with a lacrimal dilator

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

a Wescott scissors (Group WS)

The patients allocated to receive STB performed with a Wescott scissors

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

patients undergoing cataract surgery by phacoemulsification and intraocular lens implantation

Exclusion Criteria

allergy to lidocaine, history of previous retinal and strabismus surgery, bleeding disorders and oral anticoagulant use, presence of glaucoma or high IOP, thick pterygia, any pathological condition that conjunctiva and Tenon's capsule cannot be lifted away from the sclera

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Oya Yalcin Cok

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baskent University, Adana Research and Training Center

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KA19/165

Identifier Type: -

Identifier Source: org_study_id