Back to resultsEffect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intrathecal Dexmedetomidine
Intraarticular Dexmedetomidine
Bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia.
Exclusion Criteria:
- Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Intrathecal Dexmedetomidine Group
Intraarticular Dexmedetomidine Group
control Group
Arm Description
30 patients will be given Intrathecal Dexmedetomidine plus Intrathecal Bupivacaine
30 patients will be given Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine
30 patients will be given Intrathecal Bupivacaine
Outcomes
Primary Outcome Measures
postoperative pain
Assesment is done by Visual Analog Scale
Secondary Outcome Measures
c-reactive protein
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02581566
Brief Title
Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
5. Study Description
Brief Summary
Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrathecal Dexmedetomidine Group
Arm Type
Active Comparator
Arm Description
30 patients will be given Intrathecal Dexmedetomidine plus Intrathecal Bupivacaine
Arm Title
Intraarticular Dexmedetomidine Group
Arm Type
Active Comparator
Arm Description
30 patients will be given Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine
Arm Title
control Group
Arm Type
Other
Arm Description
30 patients will be given Intrathecal Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Intrathecal Dexmedetomidine
Intervention Description
Addition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Intraarticular Dexmedetomidine
Intervention Description
Addition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Intrathecal Bupivacaine
Primary Outcome Measure Information:
Title
postoperative pain
Description
Assesment is done by Visual Analog Scale
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
c-reactive protein
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia.
Exclusion Criteria:
Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
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Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
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