NCT02925832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

September 30, 2016

Last Update Submit

January 24, 2017

Conditions

Cataract Unilateral Pending ExtractionAnesthesia

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

0.75% ropivacaine soaked sponges

Also known as: Local anaesthetic
Group R
BupivacaineDRUG

0.5% bupivacaine soaked sponges

Also known as: Local anaesthetic
Group B
ProparacaineDRUG

For anaesthetising conjunctiva

Also known as: Local anesthetic
Group BGroup R

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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government medical college

Haldwani, Uttarakhand, 263139, India

Location

MeSH Terms

Interventions

RopivacaineAnesthesia, LocalBupivacaineproxymetacaineAnesthetics, Local

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Govind S Titiyal, Professor

    Head of department Ophthalmology

    STUDY CHAIR

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 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

IN(1)