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Effect of Pregabalin on the Postoperative Analgesia in RFA of Focal Lesions in the Liver (pregabalin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03151213
Recruitment Status : Unknown
Verified August 2018 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : May 12, 2017
Last Update Posted : August 27, 2018
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Cancer Drug: Pregabalin 150mg Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Double blinded by closed envelops
Primary Purpose: Treatment
Official Title: Effect of Preoperative Administration of Oral Pregabalin on the Postoperative Analgesia in Patients Scheduled for Radiofrequency Ablationof Focal Lesions in the Liver
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin
Pregabalin 150 mg before intervention
Drug: Pregabalin 150mg
Pregabalin 150mg before RFA of liver cancer
Other Name: pregab

Placebo Comparator: Placebo
Placebo before intervention
Other: Placebo
Placebo before RFA of liver cancer

Primary Outcome Measures :
  1. visual analogue pain scale (VAS Pain) post operatively [ Time Frame: 2 weeks ]
    Amplitude of pain postoperatively

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HCC patients, Child A, B, scheduled for Radiofrequency ablation of HCC.

Exclusion Criteria:

  • Encephalopathy, Renal impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03151213

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Contact: Sherief Abd-Elsalam, consultant 00201095159522

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Tanta university - faculty of medicine Recruiting
Cairo, Elgharbia, Egypt
Contact: Sherief Abdelsalam, lecturer    00201095159522   
Sponsors and Collaborators
Sherief Abd-Elsalam
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Principal Investigator: Amr Magdy Abdelfattah, consultant Tanta University Faculty of Medicine
Study Director: Sherief Abd-Elsalam, Consultant Tanta university Faculty of Medicine
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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University Identifier: NCT03151213    
Other Study ID Numbers: amr magdy
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs