Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification (DTFNB)

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

Study Overview

• Status: Completed
• Conditions: Anesthesia; Cataract Unilateral Pending Extraction
• Intervention / Treatment: Procedure: Deep Topical Fornix Nerve block anesthesia; Drug: Bupivacaine; Drug: Proparacaine; Drug: Ropivacaine

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Uttarakhand
    • Haldwani, Uttarakhand, India, 263139
      • Government Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group B; Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine	Procedure: Deep Topical Fornix Nerve block anesthesia; 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; Drug: Bupivacaine; 0.5% bupivacaine soaked sponges; Other Names: Local anaesthetic; Drug: Proparacaine; For anaesthetising conjunctiva; Other Names: Local anesthetic
EXPERIMENTAL: Group R; Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine	Procedure: Deep Topical Fornix Nerve block anesthesia; 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; Drug: Proparacaine; For anaesthetising conjunctiva; Other Names: Local anesthetic; Drug: Ropivacaine; 0.75% ropivacaine soaked sponges; Other Names: Local anaesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Government Medical College, Haldwani
• Investigators: Study Chair: Govind S Titiyal, Professor, Head of department Ophthalmology

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (ESTIMATE): October 6, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Bupivacaine; Anaesthesia; Phacoemulsification; Ropivacaine; Deep topical fornix nerve block Anesthesia; Eye surgery blocks
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Proxymetacaine; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: 273/IEC/R-26.08.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED