Enucleated; EyeNCT03507426
Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia
A study testing Retrobulbar block and Ketamine in people with Enucleated; Eye and Evisceration; Operation Wound, run by Nazmy Edward Seif at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enucleated; Eye, Evisceration; Operation Wound, Pain, Postoperative
- What is being tested?
- Retrobulbar block and Ketamine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular enucleation candidate patients
- Ocular evisceration candidate patients
Who cannot join
- Any condition contra-indicating general or local anesthesia
- Allergy to any of the drugs used during the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Retrobulbar block, Ketamine
- Keywords
- Retrobulbar block, Ketamine, Ocular enucleation, Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrobulbar blockProcedure or surgery
Also called Local analgesia
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.
KetamineProcedure or surgery
Also called IV analgesia
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrobulbar group | Active comparator | Retrobulbar block Receives: Procedure: Retrobulbar block |
| Ketamine group | Active comparator | Intravenous analgesia Receives: Procedure: Ketamine |
| Control group | No intervention | General anesthesia alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start25 Apr 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enucleated; EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Ahmed M El-Badawy, MD, Study chair, Kasr Al-Ainy Hospital, Cairo UniversityNazmy E Seif, MD, Study director, Kasr Al-Ainy Hospital, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507426
- Sponsor's protocol ID
- RBKIPEA
- Status last verified
- Jul 2020
- First submitted
- 15 Apr 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrobulbar Block Versus Ketamine Infusion as Adjuvants to General Anesthesia for Post-operative Pain Control After Enucleation
- ClinicalTrials.gov ID
- NCT03507426
- Acronym / sponsor ID
- RBKIPEA
- Keywords
- Retrobulbar block, Ketamine, Ocular enucleation, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrobulbar group | Active comparator | Procedure: Retrobulbar blockRetrobulbar block |
| Ketamine group | Active comparator | Procedure: KetamineIntravenous analgesia |
| Control group | No intervention | –General anesthesia alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ocular enucleation candidate patients
- Ocular evisceration candidate patients
Key exclusion criteria (2 listed)
- Any condition contra-indicating general or local anesthesia
- Allergy to any of the drugs used during the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrobulbar blockAlso: Local analgesiaPatients 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. | Procedure or surgery | Retrobulbar group |
| KetamineAlso: IV analgesiaPatients 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. | Procedure or surgery | Ketamine group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M El-Badawy, MD study chair
Kasr Al-Ainy Hospital, Cairo University
Nazmy E Seif, MD study director
Kasr Al-Ainy Hospital, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrobulbar block and Ketamine in people with Enucleated; Eye and Evisceration; Operation Wound, run by Nazmy Edward Seif at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first post-operative rescue analgesia. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.