Heavy Bupivacaine in Peribulbar Block
Heavy Bupivacaine Versus Plain Bupivacaine in Peribulbar Block
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedOctober 18, 2017
October 1, 2017
3 months
October 13, 2017
October 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The onset and duration of lid and globe akinesia
scoring the ocular movements in each direction of gaze
12 hours postoperative
Study Arms (2)
hyperbaric bupvacaine group
EXPERIMENTALPeribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline
isobaric bupvacaine group
ACTIVE COMPARATORPeribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline
Interventions
hyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery
isobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery
Eligibility Criteria
You may qualify if:
- Patients with American Society of Anesthesiology (ASA) I or II.
- years old
- Patients scheduled for elective unilateral posterior segment surgeries.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Giza Governorate, 1234, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Ahmed Badwy
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, 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
October 13, 2017
First Posted
October 18, 2017
Study Start
November 1, 2017
Primary Completion
January 20, 2018
Study Completion
January 31, 2018
Last Updated
October 18, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share