Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

Anesthesia Clinical Trial

— DTFNB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925832
• Other study ID #: 273/IEC/R-26.08.2016
• Status: Completed
• Phase: N/A
• First received: September 30, 2016
• Last updated: January 24, 2017
• Start date: October 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Government Medical College, Haldwani
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cataract
• Cataract Unilateral Pending Extraction

Intervention

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.

Drug:
• Ropivacaine
0.75% ropivacaine soaked sponges
• Bupivacaine
0.5% bupivacaine soaked sponges
• Proparacaine
For anaesthetising conjunctiva

Locations

Country	Name	City	State
India	Government medical college	Haldwani	Uttarakhand

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Haldwani

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Level of surgeon satisfaction	0: Poor,; Adequate,; Good	1 hour
Secondary	Incidence of Surgical complications		1 hour