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Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Retrobulbar block
Ketamine
Sponsored by
Nazmy Edward Seif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Enucleated; Eye focused on measuring Retrobulbar block, Ketamine, Ocular enucleation, Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Al-Ainy Hospital, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Retrobulbar group

Ketamine group

Control group

Arm Description

Retrobulbar block

Intravenous analgesia

General anesthesia alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 15, 2018
Last Updated
July 13, 2020
Sponsor
Nazmy Edward Seif
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1. Study Identification

Unique Protocol Identification Number
NCT03507426
Brief Title
Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia
Official Title
Retrobulbar Block Versus Ketamine Infusion as Adjuvants to General Anesthesia for Post-operative Pain Control After Enucleation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazmy Edward Seif

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enucleated; Eye, Evisceration; Operation Wound, Pain, Postoperative
Keywords
Retrobulbar block, Ketamine, Ocular enucleation, Analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrobulbar group
Arm Type
Active Comparator
Arm Description
Retrobulbar block
Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
Intravenous analgesia
Arm Title
Control group
Arm Type
No Intervention
Arm Description
General anesthesia alone
Intervention Type
Procedure
Intervention Name(s)
Retrobulbar block
Other Intervention Name(s)
Local analgesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ketamine
Other Intervention Name(s)
IV analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to the first post-operative rescue analgesia.
Description
Time (measured in minutes) elapsed till the patient requires to receive his first post-operative rescue analgesic dose.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M El-Badawy, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nazmy E Seif, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Kasr Al-Ainy Hospital, Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

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