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Heavy Bupivacaine in Peribulbar Block

NCT ID: NCT03312959

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-01-31

Brief Summary

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Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.

Detailed Description

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Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.

However, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.

Aim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.

Conditions

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Anesthetics, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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hyperbaric bupvacaine group

Peribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline

Group Type EXPERIMENTAL

hyperbaric bupvacaine in Peribulbar block

Intervention Type DRUG

hyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery

isobaric bupvacaine group

Peribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline

Group Type ACTIVE_COMPARATOR

isobaric bupvacaine in Peribulbar block

Intervention Type DRUG

isobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery

Interventions

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hyperbaric bupvacaine in Peribulbar block

hyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery

Intervention Type DRUG

isobaric bupvacaine in Peribulbar block

isobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery

Intervention Type DRUG

Other Intervention Names

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trial group control group

Eligibility Criteria

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Inclusion Criteria

* Patients with American Society of Anesthesiology (ASA) I or II.
* 30-80 years old
* Patients scheduled for elective unilateral posterior segment surgeries.

Exclusion Criteria

* Patient's refusal.
* orbital deformity
* axial length( \>28 mm )
* increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) \> 1.5
* allergy to local anesthetics, mentally retarded patients
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hassan Mohamed Ali

lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hassan Ali

Role: CONTACT

Phone: 1001733687

Email: [email protected]

Ahmed Badwy

Role: CONTACT

Other Identifiers

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badway 2

Identifier Type: -

Identifier Source: org_study_id