Clinical trial NCT02925832: Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification
Official title: Comparison Between Ropivacaine and Bupivacaine in Deep Topical Fornix Nerve Block Anesthesia in Patients Undergoing Cataract Surgery by Phacoemulsification.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Unilateral Pending Extraction
Anesthesia
Keywords: Deep topical fornix nerve block Anesthesia
Ropivacaine
Bupivacaine
Anaesthesia
Eye surgery blocks
Phacoemulsification
Lead sponsor: Government Medical College, Haldwani
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Measure level of pain and discomfort during surgery
timeFrame: 1 hours
Secondary outcomes:
measure: Number of patients where Supplemental anaesthesia was given
timeFrame: 1 hour
measure: Level of surgeon satisfaction
timeFrame: 1 hour
measure: Incidence of Surgical complications
timeFrame: 1 hour
Other outcomes:
Locations:
city: Haldwani
country: India
facility: Government medical college
state: Uttarakhand
Study officials:
affiliation: Head of department Ophthalmology
name: Govind S Titiyal, Professor
role: STUDY_CHAIR
References: