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Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

Sponsor
Nazmy Edward Seif (Other)
Overall Status
Completed
CT.gov ID
NCT03507426
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
23.2
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Retrobulbar block
  • Procedure: Ketamine
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Retrobulbar Block Versus Ketamine Infusion as Adjuvants to General Anesthesia for Post-operative Pain Control After Enucleation
Actual Study Start Date :
Apr 25, 2018
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Retrobulbar group

Retrobulbar block

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 Names:
  • Local analgesia

    		•
    Active Comparator: Ketamine group

    Intravenous 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 Names:
  • IV analgesia

    		•
    No Intervention: Control group

    General anesthesia alone

    Outcome Measures

    Primary Outcome Measures

    1. Time to the first post-operative rescue analgesia. [24 hours]

      Time (measured in minutes) elapsed till the patient requires to receive his first post-operative rescue analgesic dose.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Al-Ainy Hospital, Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Nazmy Edward Seif

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nazmy Edward Seif, Clinical Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03507426
    Other Study ID Numbers:
    • RBKIPEA
    First Posted:
    Apr 25, 2018
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nazmy Edward Seif, Clinical Professor, Cairo University
    Retrobulbar block
    Ketamine
    Ocular enucleation
    Analgesia
    Additional relevant MeSH terms:
    Pain, Postoperative
    Ketamine

    Study Results

    No Results Posted as of Jul 14, 2020