Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

Government Medical College, Haldwani

Status: Completed

Conditions: Cataract Unilateral Pending Extraction; Anesthesia

Treatments: Drug: Bupivacaine; Drug: Ropivacaine; Procedure: Deep Topical Fornix Nerve block anesthesia; Drug: Proparacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02925832

273/IEC/R-26.08.2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group B

Experimental group

Description:

Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine

Treatment:

Drug: Proparacaine

Procedure: Deep Topical Fornix Nerve block anesthesia

Drug: Bupivacaine

Group R

Experimental group

Description:

Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine

Treatment:

Drug: Proparacaine

Procedure: Deep Topical Fornix Nerve block anesthesia

Drug: Ropivacaine