Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia Procedure

NCT02196441 | Unknown DMC

• 1 other identifier: 1234656
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

General anaesthesia now a days is not the first choice in phakic intra ocular lens surgery (Phakic IOL) , the short duration of the surgery, general anaesthesia complications, decrease the length of hospital stay and decreasing the costs direct the interest to the regional anaesthesia By the time the traditional retro and peribulbar injections recede to a newer techniques that is safer and cheaper, sub tenon's block using a blunt needle took over due to the more safety profile Even though, still serious problems can occur specially in patients with long axial length. Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took over with promising and successful results, decreasing length of hospital stay and increasing patient satisfaction and fewer margins of complications. In this study the investigators compared topical anaesthesia alone with DTFNBA in patients undergoing posterior chamber phakic IOL surgery (Visian ICL).

Conditions

Local Anesthesia; Satisfaction

Keywords

deep topical fornix nerve block; topical anesthesia; implantable contact lens procedure

Outcome Measures

Primary Outcomes (1)

• Measure of pain free surgery and Tolerability

  the patient will be examined for optimum pain free condition (anesthesia)that allow the surgeon to proceed

  during the surgical procedure, 15 minutes

Secondary Outcomes (1)

• patient satisfaction

  one hour post operative

Study Arms (2)

Group 2

EXPERIMENTAL

0.5% bupivacaine Deep topical fornix nerve block anaesthesia (DTFNB)

Drug: 0.5% bupivacaine

Group 1

EXPERIMENTAL

2% tetracaine local anaesthetic drops

Drug: 2% tetracaine local anaesthetic drops

Interventions

2% tetracaine local anaesthetic drops DRUG

topical anaesthetic drops

Also known as: topical anaesthetic drops

Group 1

0.5% bupivacaine DRUG

was performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by grasping the limbus with Castroviejo 0.12 tissue forceps.

Also known as: Deep topical fornix nerve block anaesthesia

Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cooperative understanding patients

You may not qualify if:

• Very anxious patients
• coagulopathy
• refusal

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Magrabi Aseer ,KSA

Khamis Mushait, West, 516, Saudi Arabia

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hassan M Ali, Lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hassan M ALi, Lecturer

CONTACT

+201001733687; hassan364@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

SA (1)