Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

July 13, 2020 updated by: Nazmy Edward Seif

Retrobulbar Block Versus Ketamine Infusion as Adjuvants to General Anesthesia for Post-operative Pain Control After Enucleation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr Al-Ainy Hospital, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBKIPEA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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