NCT03507426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

April 15, 2018

Last Update Submit

July 13, 2020

Conditions

Enucleated; EyeEvisceration; Operation WoundPain, Postoperative

Keywords

Retrobulbar blockKetamineOcular enucleationAnalgesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Study Arms (3)

Retrobulbar group

ACTIVE COMPARATOR

Retrobulbar block

Procedure: Retrobulbar block

Ketamine group

ACTIVE COMPARATOR

Intravenous analgesia

Procedure: Ketamine

Control group

NO INTERVENTION

General anesthesia alone

Interventions

Retrobulbar blockPROCEDURE

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.

Also known as: Local analgesia
Retrobulbar group
KetaminePROCEDURE

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.

Also known as: IV analgesia
Ketamine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ocular enucleation candidate patients
  • Ocular evisceration candidate patients

You may not qualify if:

  • Any condition contra-indicating general or local anesthesia
  • Allergy to any of the drugs used during the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al-Ainy Hospital, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

KetamineAnalgesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnesthesia and Analgesia

Study Officials

  • Ahmed M El-Badawy, MD

    Kasr Al-Ainy Hospital, Cairo University

    STUDY CHAIR

  • Nazmy E Seif, MD

    Kasr Al-Ainy Hospital, Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 15, 2018

First Posted

April 25, 2018

Study Start

April 25, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

EG(1)