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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
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia, Local focused on measuring Subconjunctival bupivacaine., Strabismus surgery., Postoperative analgesia.

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 16, 2021
    Last Updated
    March 2, 2021
    Sponsor
    Fayoum University
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    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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