Peribulbar Block Versus Subtenon's Injection in Redo Vitreoretinal Surgery
subtenon's
Comparative Study Between Peribulbar Block Technique and Sub-Tenon's Technique in Adult Patients Undergoing Redo Vitreoretinal Surgery: RCT
1 other identifier
interventional
60
1 country
1
Brief Summary
To compare the efficacy and efficiency of peribulbar block versus sub-Tenon's capsule injection of local anesthetic in redo vitreoretinal surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
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
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 27, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedSeptember 13, 2022
September 1, 2022
1.2 years
July 2, 2021
September 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
intraoperative pain
11 point verbal rating score from 0 to 10 where 0 is no pain and 10 is intolerable pain patient will be asked immediately after surgery about pain the need for intraoperative sedation will be recorded
during whole surgery duration (around 2 hours)
Study Arms (2)
subtenon's block
EXPERIMENTALwe use the subtenon cannula to inject the local anesthetic mixture
peribulbar block
EXPERIMENTALwe use the usual 25G sharp needle to inject the local anesthetic mixture
Interventions
Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.75% bupivacaine with 60 IU hyalouronic acid. two groups 30 patient each (group p and group s) after connecting the patient to the monitor, we give him sedation 50 mg propofol, apply a nasal cannula group P: receives 2 injection peribulbar block group S: receives single injection subtenon Patients rate their pain sensation in both groups using an 11-point (0-10) numerical visual analogue scale immediately after surgery.
Eligibility Criteria
You may qualify if:
- age between 18 and 80
You may not qualify if:
- Uncooperative patients
- Bleeding disorders
- High axial length (30mm) with previous buckle surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abeer Samir Salemlead
- Research Institute of Ophthalmology, Egyptcollaborator
Study Sites (1)
Research Institute of Ophthalmology
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abeer Samir, MD
research institute of ophthalmology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Researcher of anesthesia
Study Record Dates
First Submitted
July 2, 2021
First Posted
July 27, 2021
Study Start
October 1, 2021
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
September 13, 2022
Record last verified: 2022-09