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

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Unknown status
CT.gov ID
NCT03151213
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
31
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pregabalin

Pregabalin 150 mg before intervention

Drug: Pregabalin 150mg
Pregabalin 150mg before RFA of liver cancer
Other Names:
  • pregab

    		•
    Placebo Comparator: Placebo

    Placebo before intervention

    Other: Placebo
    Placebo before RFA of liver cancer

    Outcome Measures

    Primary Outcome Measures

    1. visual analogue pain scale (VAS Pain) post operatively [2 weeks]

      Amplitude of pain postoperatively

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta university - faculty of medicine Cairo Elgharbia Egypt

    Sponsors and Collaborators

    • Sherief Abd-Elsalam

    Investigators

    • Principal Investigator: Amr Magdy Abdelfattah, consultant, Tanta University Faculty of Medicine
    • Study Director: Sherief Abd-Elsalam, Consultant, Tanta university Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT03151213
    Other Study ID Numbers:
    • amr magdy
    First Posted:
    May 12, 2017
    Last Update Posted:
    Aug 27, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Neoplasms
    Carcinoma, Hepatocellular
    Pregabalin

    Study Results

    No Results Posted as of Aug 27, 2018