Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract Unilateral Pending Extraction Anesthesia

Keywords

Deep topical fornix nerve block AnesthesiaRopivacaineBupivacaineAnaesthesiaEye surgery blocksPhacoemulsification

Outcome Measures

Primary Outcomes (1)

Measure level of pain and discomfort during surgery
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
1 hours

Secondary Outcomes (3)

Number of patients where Supplemental anaesthesia was given
1 hour
Level of surgeon satisfaction
1 hour
Incidence of Surgical complications
1 hour

Study Arms (2)

Group B

EXPERIMENTAL

Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine

Procedure: Deep Topical Fornix Nerve block anesthesiaDrug: BupivacaineDrug: Proparacaine

Group R

EXPERIMENTAL

Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine

Procedure: Deep Topical Fornix Nerve block anesthesiaDrug: RopivacaineDrug: Proparacaine

Interventions

Deep Topical Fornix Nerve block anesthesiaProcedure

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.

Also known as: DTFNB

Group BGroup R

RopivacaineDrug

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Government Medical College, Haldwani
Otherlead

Study Sites (1)

Government medical college

Haldwani, Uttarakhand, 263139, India

MeSH Terms

Interventions

RopivacaineAnesthesia, LocalBupivacaineproxymetacaineAnesthetics, Local

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnestheticsCentral Nervous System Depressants

Study Officials

Govind S Titiyal, Professor
Head of department Ophthalmology
STUDY CHAIR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Post Graduate

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 6, 2016

Study Start

October 2016

Date type not reported

This date has not been verified as actual or estimated.

Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Group B

Group R

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Group B

Group R

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations