Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

Ketamine

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.

Intervention / Treatment

  • Retrobulbar block (PROCEDURE)
    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.
  • Ketamine (PROCEDURE)
    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.

Condition or Disease

  • Enucleated; Eye
  • Evisceration; Operation Wound
  • Pain, Postoperative

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 45 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 25, 2018 ACTUAL
    Primary Completion: Mar 31, 2020 ACTUAL
    Completion Date: Mar 31, 2020 ACTUAL
    Study First Posted: Apr 25, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 13, 2020

    Sponsors / Collaborators

    Lead Sponsor: Nazmy Edward Seif
    Responsible Party: Nazmy Edward Seif

    Location

    Cairo, Egypt

    Participant Groups

    • Retrobulbar block

    • Intravenous analgesia

    • General anesthesia alone

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

    More Details

    NCT Number: NCT03507426
    Other IDs: RBKIPEA
    Study URL: https://clinicaltrials.gov/study/NCT03507426
    Last updated: Sep 29, 2023