Skip to main content
OpenTrials
Completed

NCT Number: NCT02925832

Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Government medical college

Haldwani, Uttarakhand, 263139, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Topical Fornix Nerve block anesthesia

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.

Other names: DTFNB

Ropivacaine

Drug

0.75% ropivacaine soaked sponges

Other names: Local anaesthetic

Bupivacaine

Drug

0.5% bupivacaine soaked sponges

Other names: Local anaesthetic

Proparacaine

Drug

For anaesthetising conjunctiva

Other names: Local anesthetic

Primary outcomes

  1. Measure level of pain and discomfort during surgery

    Time frame: 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 outcomes

  1. Number of patients where Supplemental anaesthesia was given

    Time frame: 1 hour

    Pain score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.

  2. Level of surgeon satisfaction

    Time frame: 1 hour

    0: Poor,

    • Adequate,
    • Good
  3. Incidence of Surgical complications

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Government Medical College, Haldwani

Other

Registry information

Official study title

Comparison Between Ropivacaine and Bupivacaine in Deep Topical Fornix Nerve Block Anesthesia in Patients Undergoing Cataract Surgery by Phacoemulsification.

Acronym: DTFNB

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2016
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.