Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract Unilateral Pending Extraction, Anesthesia

Intervention / Treatment
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* Procedure: Deep Topical Fornix Nerve block anesthesia
* Drug: Ropivacaine
* Drug: Bupivacaine
* Drug: Proparacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br>Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine | Procedure: Deep Topical Fornix Nerve block anesthesia<br>* 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.<br>* Other names: DTFNB;Drug: Bupivacaine<br>* 0.5% bupivacaine soaked sponges<br>* Other names: Local anaesthetic;Drug: Proparacaine<br>* For anaesthetising conjunctiva<br>* Other names: Local anesthetic;|
| Experimental: Group R<br>Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine | Procedure: Deep Topical Fornix Nerve block anesthesia<br>* 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.<br>* Other names: DTFNB;Drug: Ropivacaine<br>* 0.75% ropivacaine soaked sponges<br>* Other names: Local anaesthetic;Drug: Proparacaine<br>* For anaesthetising conjunctiva<br>* Other names: Local anesthetic;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep topical fornix nerve block Anesthesia, Ropivacaine, Bupivacaine, Anaesthesia, Eye surgery blocks, Phacoemulsification