Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

Not Applicable

Completed

• Conditions: Cataract Unilateral Pending Extraction; Anesthesia
• Interventions: Procedure: Deep Topical Fornix Nerve block anesthesia; Drug: Bupivacaine; Drug: Ropivacaine; Drug: Proparacaine

• Registration Number: NCT02925832
• Lead Sponsor: Government Medical College, Haldwani

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.

Study Timeline

• Study First Submitted: 2016-09-30
• Study Start: 2016-10
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Deep Topical Fornix Nerve block anesthesia	Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
Group B	Bupivacaine	Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
Group R	Deep Topical Fornix Nerve block anesthesia	Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine
Group B	Proparacaine	Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
Group R	Ropivacaine	Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine
Group R	Proparacaine	Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine

Primary Outcome Measures

Name	Time	Method
Measure level of pain and discomfort during surgery	1 hours	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

Secondary Outcome Measures

Name	Time	Method
Level of surgeon satisfaction	1 hour	0: Poor,; 1. Adequate,; 2. Good
Number of patients where Supplemental anaesthesia was given	1 hour	Pain score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.
Incidence of Surgical complications	1 hour

Trial Locations

Locations (1)

Government medical college; 🇮🇳 Haldwani, Uttarakhand, India