Subconjunctival Bupivacaine in Strabismus Surgery
The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.
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 Apr 2021
Shorter than P25 for not_applicable
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
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMarch 4, 2021
March 1, 2021
1 month
February 16, 2021
March 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analog scale (VAS) pain score
Range, 0\_10;0,no pain ;10,worst pain
5 minutes after extubation
Secondary Outcomes (1)
Nausea and vomiting
24 hours postoperatively
Other Outcomes (8)
Patient satisfaction
24 hours postoperatively
Visual analog scale (VAS) pain score
30 minutes after extubation
Visual analog scale (VAS) pain score
60 minutes after extubation
- +5 more other outcomes
Study Arms (2)
20 patients receive Subconjunctival bupivacaine of the end of the surgery
ACTIVE COMPARATOR20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score
20 patients receive Subconjunctival placebo in the end of operation
PLACEBO COMPARATOR20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score
Interventions
Local anaesthetic Subconjunctival bupivacaine
0.9 saline
Eligibility Criteria
You may qualify if:
- All patients aged 14 \_30 years old with body mass index 18\_28kg/m.
- American Anaesthesiologist Association physical states I,II.
- singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.
You may not qualify if:
- were patients with chronic pain.
- ocular hypertension.
- inability to communicate.
- history of hematological disease.
- allergy to local anesthetic drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammad A Hamed, MD
Fayoum University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecture of Anesthesiology
Study Record Dates
First Submitted
February 16, 2021
First Posted
March 4, 2021
Study Start
April 1, 2021
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
March 4, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share