Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

NCT ID: NCT02925832

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2016-12-31

Brief Summary

Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract surgeries by phacoemulsification. In this study the investigators intend to compare ropivacaine and bupivacaine in various parameters during phacoemulsification.

Detailed Description

Prospective, study will be conducted on 100 patients undergoing elective cataract surgery by phacoemulsification under Deep topical fornix nerve block at Government medical college, Haldwani, India.

Written informed consent to participate in the study will be taken from all the patients.

Patients will be randomly allocated into two groups, Groups B (Bupivacaine: n=50) and Group R (Ropivacaine: n =50).

Deep topical fornix nerve block (DTFNB) would be performed using two sponges (2x3 mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anesthetizing the conjunctiva with proparacaine local anesthetic drops. The sponges are to be removed after 15-20 minutes. The anesthetic effect will be tested by grasping the limbus with Castroviejo 0.12 tissue forceps. No sedative systemic medications will be given to patients perioperatively.

All surgeries will be performed by the same surgeon. Both patients and surgeon will be blind to which anesthetic agent would be used. A 2.8mm scleral tunnel incision will be made, followed by capsulorhexis. The nucleus would be removed by the stop and chop technique followed by irrigation aspiration of the cortex. Foldable acrylic intraocular lens would be implanted in the capsular bag followed by wash of the viscoelastic and hydration of the side ports.

A simple pain scoring system will be used during the surgery (0: No pain; 1: Discomfort; 2: Pain). Assessment will be made by verbally asking the patient to score each step of the surgery i.e. scleral tunnel Incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation aspiration, intraocular lens implantation and stromal hydration.

In case the score being 0 or 1 no intervention will be done. But in cases of score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.

Conditions

Cataract Unilateral Pending Extraction; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group B

Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine

Group Type: EXPERIMENTAL

Deep Topical Fornix Nerve block anesthesia

Intervention Type: PROCEDURE

DTFNB would be performed using two sponges (2x3mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with proparacaine local anaesthetic drops. The sponges are to be removed after 15 minutes.

Bupivacaine

Intervention Type: DRUG

0.5% bupivacaine soaked sponges

Proparacaine

Intervention Type: DRUG

For anaesthetising conjunctiva

Group R

Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine

Group Type: EXPERIMENTAL

Deep Topical Fornix Nerve block anesthesia

Intervention Type: PROCEDURE

DTFNB would be performed using two sponges (2x3mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with proparacaine local anaesthetic drops. The sponges are to be removed after 15 minutes.

Ropivacaine

Intervention Type: DRUG

0.75% ropivacaine soaked sponges

Proparacaine

Intervention Type: DRUG

For anaesthetising conjunctiva

Interventions

Deep Topical Fornix Nerve block anesthesia

DTFNB would be performed using two sponges (2x3mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with proparacaine local anaesthetic drops. The sponges are to be removed after 15 minutes.

Intervention Type: PROCEDURE

Ropivacaine

0.75% ropivacaine soaked sponges

Intervention Type: DRUG

Bupivacaine

0.5% bupivacaine soaked sponges

Intervention Type: DRUG

Proparacaine

For anaesthetising conjunctiva

Intervention Type: DRUG

Other Intervention Names

DTFNB; Local anaesthetic; Local anaesthetic; Local anesthetic

Eligibility Criteria

Inclusion Criteria

• Anaesthesiologists Physical Status classification system (ASA I-II) to undergo planned cataract surgery by phacoemulsification.

Exclusion Criteria

• Younger than 50 years,
• Had any psychiatric illness (including significant anxiety),
• Nystagmus,
• Insufficient pupil dilatation,
• Very hard cataracts (NS 4-5),
• Allergy to local anaesthetics,
• Inability to understand language or
• Patient refuses the topical anaesthesia technique

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Medical College, Haldwani

OTHER

Sponsor Role: lead

Responsible Party

Dr Rahul Varshney

Post Graduate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Govind S Titiyal, Professor

Role: STUDY_CHAIR

Head of department Ophthalmology

Locations

Government medical college

Haldwani, Uttarakhand, India

Countries

India

Other Identifiers

273/IEC/R-26.08.2016

Identifier Type: -

Identifier Source: org_study_id