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Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

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.
 
ClinicalTrials.gov Identifier: NCT03507426
Recruitment Status : Completed
First Posted : April 25, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Nazmy Edward Seif, Cairo University

Tracking Information
First Submitted Date  ICMJE April 15, 2018
First Posted Date  ICMJE April 25, 2018
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE April 25, 2018
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
Time to the first post-operative rescue analgesia. [ Time Frame: 24 hours ]
Time (measured in minutes) elapsed till the patient requires to receive his first post-operative rescue analgesic dose.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Visual Analogue Score (VAS) [ Time Frame: 24 hours ]
Visual Analogue Score for pain graded from 0-10 [0: no pain, 10: worst pain]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia
Official Title  ICMJE Retrobulbar Block Versus Ketamine Infusion as Adjuvants to General Anesthesia for Post-operative Pain Control After Enucleation
Brief Summary This study compares the efficacy and safety of two techniques, retrobulbar block versus intra-operative ketamine infusion, for control of post-operative pain occurring in patients undergoing ocular enucleation or evisceration performed under general anesthesia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Enucleated; Eye
  • Evisceration; Operation Wound
  • Pain, Postoperative
Intervention  ICMJE
  • Procedure: Retrobulbar block
    Patients will receive a single retrobulbar injection with 3-4ml of an equal mixture of Lidocaine 2% & Bupivacaine 0.5% + Hyaluronidase (10 IU/ml), after induction of general anesthesia.
    Other Name: Local analgesia
  • Procedure: Ketamine
    Patients will receive a 0.5 mg/kg bolus followed by an infusion of 0.25 mg/kg/h of intravenous Ketamine, after induction of general anesthesia.
    Other Name: IV analgesia
Study Arms  ICMJE
  • Active Comparator: Retrobulbar group
    Retrobulbar block
    Intervention: Procedure: Retrobulbar block
  • Active Comparator: Ketamine group
    Intravenous analgesia
    Intervention: Procedure: Ketamine
  • No Intervention: Control group
    General anesthesia alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ocular enucleation candidate patients
  • Ocular evisceration candidate patients

Exclusion Criteria:

  • Any condition contra-indicating general or local anesthesia
  • Allergy to any of the drugs used during the procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03507426
Other Study ID Numbers  ICMJE RBKIPEA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nazmy Edward Seif, Cairo University
Study Sponsor  ICMJE Nazmy Edward Seif
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ahmed M El-Badawy, MD Kasr Al-Ainy Hospital, Cairo University
Study Director: Nazmy E Seif, MD Kasr Al-Ainy Hospital, Cairo University
PRS Account Cairo University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP