Back to resultsEffect of Pregabalin on the Postoperative Analgesia in RFA of Focal Lesions in the Liver (pregabalin)
Primary Purpose
Hepatocellular Cancer
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Pregabalin 150mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Cancer
Eligibility Criteria
Inclusion Criteria:
- HCC patients, Child A, B, scheduled for Radiofrequency ablation of HCC.
Exclusion Criteria:
- Encephalopathy, Renal impairment
Sites / Locations
- Tanta university - faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pregabalin
Placebo
Arm Description
Pregabalin 150 mg before intervention
Placebo before intervention
Outcomes
Primary Outcome Measures
visual analogue pain scale (VAS Pain) post operatively
Amplitude of pain postoperatively
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03151213
Brief Title
Effect of Pregabalin on the Postoperative Analgesia in RFA of Focal Lesions in the Liver
Acronym
pregabalin
Official Title
Effect of Preoperative Administration of Oral Pregabalin on the Postoperative Analgesia in Patients Scheduled for Radiofrequency Ablationof Focal Lesions in the Liver
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
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
The study aimed to investigate the preemptive analgesia efficacy of of preemptive pregabalin for the postoperative pain management after radiofrequency ablation (RFA) of liver cancer.
Detailed Description
Our data will investigate if preemptive administration of pregabalin will have a role in reducing postoperative pain after radiofrequency ablation (RFA) of liver cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Double blinded by closed envelops
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
Pregabalin 150 mg before intervention
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo before intervention
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Other Intervention Name(s)
pregab
Intervention Description
Pregabalin 150mg before RFA of liver cancer
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo before RFA of liver cancer
Primary Outcome Measure Information:
Title
visual analogue pain scale (VAS Pain) post operatively
Description
Amplitude of pain postoperatively
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HCC patients, Child A, B, scheduled for Radiofrequency ablation of HCC.
Exclusion Criteria:
Encephalopathy, Renal impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, consultant
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Magdy Abdelfattah, consultant
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Consultant
Organizational Affiliation
Tanta university Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Cairo
State/Province
Elgharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abdelsalam, lecturer
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Pregabalin on the Postoperative Analgesia in RFA of Focal Lesions in the Liver
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