Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification (DTFNB)
Primary Purpose
Cataract Unilateral Pending Extraction, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Deep Topical Fornix Nerve block anesthesia
Ropivacaine
Bupivacaine
Proparacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract Unilateral Pending Extraction focused on measuring Deep topical fornix nerve block Anesthesia, Ropivacaine, Bupivacaine, Anaesthesia, Eye surgery blocks, Phacoemulsification
Eligibility Criteria
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
Sites / Locations
- Government medical college
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group B
Group R
Arm Description
Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Level of surgeon satisfaction
0: Poor,
Adequate,
Good
Incidence of Surgical complications
Full Information
NCT ID
NCT02925832
First Posted
September 30, 2016
Last Updated
January 24, 2017
Sponsor
Government Medical College, Haldwani
1. Study Identification
Unique Protocol Identification Number
NCT02925832
Brief Title
Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification
Acronym
DTFNB
Official Title
Comparison Between Ropivacaine and Bupivacaine in Deep Topical Fornix Nerve Block Anesthesia in Patients Undergoing Cataract Surgery by Phacoemulsification.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Medical College, Haldwani
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Unilateral Pending Extraction, Anesthesia
Keywords
Deep topical fornix nerve block Anesthesia, Ropivacaine, Bupivacaine, Anaesthesia, Eye surgery blocks, Phacoemulsification
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B
Arm Type
Experimental
Arm Description
Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
Arm Title
Group R
Arm Type
Experimental
Arm Description
Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine
Intervention Type
Procedure
Intervention Name(s)
Deep Topical Fornix Nerve block anesthesia
Other Intervention Name(s)
DTFNB
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Local anaesthetic
Intervention Description
0.75% ropivacaine soaked sponges
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Local anaesthetic
Intervention Description
0.5% bupivacaine soaked sponges
Intervention Type
Drug
Intervention Name(s)
Proparacaine
Other Intervention Name(s)
Local anesthetic
Intervention Description
For anaesthetising conjunctiva
Primary Outcome Measure Information:
Title
Measure level of pain and discomfort during surgery
Description
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
Time Frame
1 hours
Secondary Outcome Measure Information:
Title
Number of patients where Supplemental anaesthesia was given
Description
Pain score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.
Time Frame
1 hour
Title
Level of surgeon satisfaction
Description
0: Poor,
Adequate,
Good
Time Frame
1 hour
Title
Incidence of Surgical complications
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Govind S Titiyal, Professor
Organizational Affiliation
Head of department Ophthalmology
Official's Role
Study Chair
Facility Information:
Facility Name
Government medical college
City
Haldwani
State/Province
Uttarakhand
ZIP/Postal Code
263139
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification
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