Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

NCT ID: NCT03507426

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2020-03-31

Brief Summary

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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

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Conditions

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Enucleated; Eye Evisceration; Operation Wound Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Retrobulbar group

Retrobulbar block

Group Type ACTIVE_COMPARATOR

Retrobulbar block

Intervention Type 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 group

Intravenous analgesia

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type 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.

Control group

General anesthesia alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Local analgesia IV analgesia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nazmy Edward Seif

OTHER

Sponsor Role lead

Responsible Party

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Nazmy Edward Seif

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed M El-Badawy, MD

Role: STUDY_CHAIR

Kasr Al-Ainy Hospital, Cairo University

Nazmy E Seif, MD

Role: STUDY_DIRECTOR

Kasr Al-Ainy Hospital, Cairo University

Locations

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Kasr Al-Ainy Hospital, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RBKIPEA

Identifier Type: -

Identifier Source: org_study_id

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