Cataract Unilateral Pending ExtractionDTFNBNCT02925832
Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification
A study testing Deep Topical Fornix Nerve block anesthesia, Ropivacaine and Bupivacaine in people with Cataract Unilateral Pending Extraction and Anesthesia, run by Government Medical College, Haldwani at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Unilateral Pending Extraction, Anesthesia
- What is being tested?
- Deep Topical Fornix Nerve block anesthesia, Ropivacaine and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anaesthesiologists Physical Status classification system (ASA I-II) to undergo planned cataract surgery by phacoemulsification.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract Unilateral Pending Extraction, Anesthesia
- Being tested
- Deep Topical Fornix Nerve block anesthesia, Ropivacaine, Bupivacaine, Proparacaine
- Keywords
- Deep topical fornix nerve block Anesthesia, Ropivacaine, Bupivacaine, Anaesthesia, Eye surgery blocks, Phacoemulsification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Topical Fornix Nerve block anesthesiaProcedure or surgery
Also called DTFNB
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.
RopivacaineDrug
Also called Local anaesthetic
0.75% ropivacaine soaked sponges
BupivacaineDrug
Also called Local anaesthetic
0.5% bupivacaine soaked sponges
ProparacaineDrug
Also called Local anesthetic
For anaesthetising conjunctiva
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine Receives: Procedure: Deep Topical Fornix Nerve block anesthesia; Drug: Bupivacaine; Drug: Proparacaine |
| Group R | Experimental | Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine Receives: Procedure: Deep Topical Fornix Nerve block anesthesia; Drug: Ropivacaine; Drug: Proparacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hours
Secondary outcomes (3)
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.
Measured: 1 hour
Level of surgeon satisfaction
0: Poor,
- Adequate,
- Good
Measured: 1 hour
Incidence of Surgical complications
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract Unilateral Pending ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Haldwani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rahul Varshney, Government Medical College, Haldwani
- Investigators
- Govind S Titiyal, Professor, Study chair, Head of department Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925832
- Sponsor's protocol ID
- 273/IEC/R-26.08.2016
- Acronym
- DTFNB
- Status last verified
- Jan 2017
- First submitted
- 30 Sep 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ropivacaine and Bupivacaine in Deep Topical Fornix Nerve Block Anesthesia in Patients Undergoing Cataract Surgery by Phacoemulsification.
- ClinicalTrials.gov ID
- NCT02925832
- Acronym / sponsor ID
- DTFNB / 273/IEC/R-26.08.2016
- Conditions
- Cataract Unilateral Pending Extraction, Anesthesia
- Keywords
- Deep topical fornix nerve block Anesthesia, Ropivacaine, Bupivacaine, Anaesthesia, Eye surgery blocks, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Government Medical College, HaldwaniUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Procedure: Deep Topical Fornix Nerve block anesthesia, Drug: Bupivacaine, Drug: ProparacaineDeep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine |
| Group R | Experimental | Procedure: Deep Topical Fornix Nerve block anesthesia, Drug: Ropivacaine, Drug: ProparacaineDeep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anaesthesiologists Physical Status classification system (ASA I-II) to undergo planned cataract surgery by phacoemulsification.
Key exclusion criteria (8 listed)
- Younger than 50 years,
- Had any psychiatric illness (including significant anxiety),
- Nystagmus,
- Insufficient pupil dilatation,
- Very hard cataracts (NS 4-5),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Topical Fornix Nerve block anesthesiaAlso: DTFNBDTFNB 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. | Procedure or surgery | Group B, Group R |
| RopivacaineAlso: Local anaesthetic0.75% ropivacaine soaked sponges | Drug | Group R |
| BupivacaineAlso: Local anaesthetic0.5% bupivacaine soaked sponges | Drug | Group B |
| ProparacaineAlso: Local anestheticFor anaesthetising conjunctiva | Drug | Group B, Group R |
Primary outcome
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
3 secondary outcomes
Number of patients where Supplemental anaesthesia was given
Time frame: 1 hour
Level of surgeon satisfaction
Time frame: 1 hour
Incidence of Surgical complications
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Govind S Titiyal, Professor study chair
Head of department Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Topical Fornix Nerve block anesthesia, Ropivacaine and Bupivacaine in people with Cataract Unilateral Pending Extraction and Anesthesia, run by Government Medical College, Haldwani at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure level of pain and discomfort during surgery (time frame: 1 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.