Subconjunctival Bupivacaine in Strabismus Surgery
Primary Purpose
Anesthesia, Local
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iocal anaesthetic bupivacaine
Placebo
Sponsored by
About this trial
This is an interventional other trial for Anesthesia, Local focused on measuring Subconjunctival bupivacaine., Strabismus surgery., Postoperative analgesia.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- were patients with chronic pain.
- ocular hypertension.
- inability to communicate.
- history of hematological disease.
- allergy to local anesthetic drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
20 patients receive Subconjunctival bupivacaine of the end of the surgery
20 patients receive Subconjunctival placebo in the end of operation
Arm Description
20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score
20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score
Outcomes
Primary Outcome Measures
Visual analog scale (VAS) pain score
Range, 0_10;0,no pain ;10,worst pain
Secondary Outcome Measures
Nausea and vomiting
Operation related side effect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04782960
Brief Title
Subconjunctival Bupivacaine in Strabismus Surgery
Official Title
The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.
Detailed Description
40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local
Keywords
Subconjunctival bupivacaine., Strabismus surgery., Postoperative analgesia.
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
20 patients receive Subconjunctival bupivacaine of the end of the surgery
Arm Type
Active Comparator
Arm Description
20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score
Arm Title
20 patients receive Subconjunctival placebo in the end of operation
Arm Type
Placebo Comparator
Arm Description
20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score
Intervention Type
Drug
Intervention Name(s)
Iocal anaesthetic bupivacaine
Other Intervention Name(s)
Group (p)
Intervention Description
Local anaesthetic Subconjunctival bupivacaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Group (s)
Intervention Description
0.9 saline
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
5 minutes after extubation
Secondary Outcome Measure Information:
Title
Nausea and vomiting
Description
Operation related side effect
Time Frame
24 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
Will be evaluated according to satisfaction score (poor=0, fair=1, good=2, excellent=3)
Time Frame
24 hours postoperatively
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
30 minutes after extubation
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
60 minutes after extubation
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
2 hours after extubation
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
4 hours after extubation
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
6 hours after extubation
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
12 hours after extubation
Title
Visual analog scale (VAS) pain score
Description
Range, 0_10;0,no pain ;10,worst pain
Time Frame
24 hours after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
were patients with chronic pain.
ocular hypertension.
inability to communicate.
history of hematological disease.
allergy to local anesthetic drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer Sh Goda
Phone
01005151706
Email
Asg06@fayoum.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amr H Mahmoud, Msc
Phone
01004349592
Ext
002
Email
Ah1240@fayoum.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad A Hamed, MD
Organizational Affiliation
Fayoum University Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Subconjunctival Bupivacaine in Strabismus Surgery
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