Back to resultsPlatelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
Primary Purpose
Platelet-rich Plasma in Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Platelet-rich Plasma
Control
Sponsored by
About this trial
This is an interventional prevention trial for Platelet-rich Plasma in Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Elective gynecological surgery.
Exclusion Criteria:
- Spinal Pathology
Sites / Locations
- Assiut University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Platelet-rich Plasma
Control
Arm Description
30 patients will receive platelet-rich plasma post-spinal anesthesia
30 patients will receive sterile saline post-spinal anesthesia
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02970058
Brief Title
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
Official Title
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet-rich Plasma in Low Back Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet-rich Plasma
Arm Type
Active Comparator
Arm Description
30 patients will receive platelet-rich plasma post-spinal anesthesia
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
30 patients will receive sterile saline post-spinal anesthesia
Intervention Type
Other
Intervention Name(s)
Platelet-rich Plasma
Intervention Description
The active group will receive Platelet-rich Plasma following spinal injection
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control group will receive saline as a placebo
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Time Frame
7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective gynecological surgery.
Exclusion Criteria:
Spinal Pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohmed Bakri, prof
Phone
+20882413201
Email
mhbakri@gmail.com
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
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