Back to resultsRetrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia
Primary Purpose
Enucleated; Eye, Evisceration; Operation Wound, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Retrobulbar block
Ketamine
Sponsored by
About this trial
This is an interventional supportive care trial for Enucleated; Eye focused on measuring Retrobulbar block, Ketamine, Ocular enucleation, Analgesia
Eligibility Criteria
Inclusion Criteria:
- Ocular enucleation candidate patients
- Ocular evisceration candidate patients
Exclusion Criteria:
- Any condition contra-indicating general or local anesthesia
- Allergy to any of the drugs used during the procedure
Sites / Locations
- Kasr Al-Ainy Hospital, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Retrobulbar group
Ketamine group
Control group
Arm Description
Retrobulbar block
Intravenous analgesia
General anesthesia alone
Outcomes
Primary Outcome Measures
Time to the first post-operative rescue analgesia.
Time (measured in minutes) elapsed till the patient requires to receive his first post-operative rescue analgesic dose.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03507426
Brief Title
Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia
Official Title
Retrobulbar Block Versus Ketamine Infusion as Adjuvants to General Anesthesia for Post-operative Pain Control After Enucleation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazmy Edward Seif
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study compares the efficacy and safety of two techniques, retrobulbar block versus intra-operative ketamine infusion, for control of post-operative pain occurring in patients undergoing ocular enucleation or evisceration performed under general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enucleated; Eye, Evisceration; Operation Wound, Pain, Postoperative
Keywords
Retrobulbar block, Ketamine, Ocular enucleation, Analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retrobulbar group
Arm Type
Active Comparator
Arm Description
Retrobulbar block
Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
Intravenous analgesia
Arm Title
Control group
Arm Type
No Intervention
Arm Description
General anesthesia alone
Intervention Type
Procedure
Intervention Name(s)
Retrobulbar block
Other Intervention Name(s)
Local analgesia
Intervention Description
Patients will receive a single retrobulbar injection with 3-4ml of an equal mixture of Lidocaine 2% & Bupivacaine 0.5% + Hyaluronidase (10 IU/ml), after induction of general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Ketamine
Other Intervention Name(s)
IV analgesia
Intervention Description
Patients will receive a 0.5 mg/kg bolus followed by an infusion of 0.25 mg/kg/h of intravenous Ketamine, after induction of general anesthesia.
Primary Outcome Measure Information:
Title
Time to the first post-operative rescue analgesia.
Description
Time (measured in minutes) elapsed till the patient requires to receive his first post-operative rescue analgesic dose.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular enucleation candidate patients
Ocular evisceration candidate patients
Exclusion Criteria:
Any condition contra-indicating general or local anesthesia
Allergy to any of the drugs used during the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M El-Badawy, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nazmy E Seif, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Kasr Al-Ainy Hospital, Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia
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