Pediatric Squint SurgeriesNCT05728151
Comparing General Anesthesia With Single Injection Peribulbar Block With 3 Different Drugs
A study testing Articaine and Epinephrine Only Product, levobupivacaine and mepivacaine in people with Pediatric Squint Surgeries, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
Trial summary
To compare the effect of the used local anesthetics in this study on decreasing the incidence of oculocardiac reflex . To evaluate the efficacy of Articaine 4 % , mepivacaine 3% and lidocaine 2% regarding post- operative analgesia. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Pediatric Squint Surgeries
- What is being tested?
- Articaine and Epinephrine Only Product, levobupivacaine and mepivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2022to 18 Apr 2024
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with ASA I , II.
- Age from 7 to 14 years old.
- Patients undergoing Strabismus Surgery
Who cannot join
- Patients with ASA III ,IV.
- Patients with Endophthalmitis , orbital fractures.
- Any Congenital or Cardiac anomalies.
- Patients with history of allergy to local anesthetics.
- Revision Surgeries.
- Refusal of the Surgeon. Refusal of the patients' parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing General Anesthesia With Single Injection Peribulbar Block With Articaine 4% vs Lidocaine 2% vs Mepivacaine 3 % for Prevention of Oculocardiac Reflex in Children Undergoing Strabismus Surgery : A Randomized Control Study
To compare the effect of the used local anesthetics in this study on decreasing the incidence of oculocardiac reflex . To evaluate the efficacy of Articaine 4 % , mepivacaine 3% and lidocaine 2% regarding post- operative analgesia.
Read the detailed description
Population of study: Children undergoing strabismus surgery aged from 7 to 14 years .
- 55 participants grouped randomly into 3 groups :
- Group A :will receive General Anesthesia combined with Peribulbar Block with 5ml of Articaine 4% with 1/100000 adrenaline and 10 International Units (IU) of Hyaluronidase .
- Group L :will receive General Anesthesia combined with Peribulbar Block with 5ml of Lidocaine 2% and 10 IU of Hyaluronidase .
- Group M : will receive General Anesthesia combined with Peribulbar Block with 5 ml of mepivacaine 3% and 10 IU of Hyaluronidase
- Methodology in details:
After obtaining informed written consent from the parents of children after explaining the procedure to them, random allocation of patients into three groups will be done.
In all groups: upon arrival to the operating room, preoperative sedatives in the form of midazolam 0.05 mg/kg by Intravenous route will be used ,standard monitor including; electrocardiogram (ECG), non-invasive blood pressure and pulse oximeter were attached to the patients. The induction of anesthesia will be by intravenous route .
Insertion of 24-22 Gauge Intravenous (IV) catheter and appropriate size laryngeal mask airway (LMA) will be inserted . Anesthesia will be maintained using 100% oxygen and sevoflurane with spontaneous respiration and capnogram will be attached to obtain continuous measurement of end-tidal carbon dioxide (ETCO2).
For group A : General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Articaine 4 % with adrenaline 1/100000 mixed with 10IU of Hyaluronidase by a single injection technique: a 26/27 gauge needle will be inserted as far laterally as possible in the inferotemporal quadrant. Once the needle is under the globe, it will be directed along the orbital floor, passing the globe equator to a depth controlled by observing the needle/hub junction reaching the plane of the iris. After negative aspiration for blood, with the globe in primary gaze, and start injection and the injected volume will be guided by digital intraocular pressure. For Group L : General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Lidocaine 2%mixed with 10IU of Hyaluronidase by a single injection technique. For group M: General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml (according to the volume of the eye) of Mepivacaine 3% mixed with 10IU of Hyaluronidase by a single injection technique. In all of the three groups Intraoperative continuous monitoring with electrocardiography monitor, pulse oximeter and Capnography will be done, and adequate hydration will be taken care of with IV fluid ringer lactate until the oral intake is allowed. In all Groups :monitoring for the incidence of Oculocardiac reflex will be done within (2-3) mins after induction of general anesthesia and giving the Peribulbar Block which is the time of required for draping and sterilization of the eye, there will be intraoperative monitoring for the incidence of Oculocardiac reflex during eye manipulations , good attention for the depth of anesthesia, any rise or drop in the Heart Rate or the Blood Pressure . Intraoperative analgesics using Fentanyl in a dose of 1 mcg/kg will be given intravenously to the patients.
Prophylaxis against post-operative vomiting will be done using Granisterone in a dose of 0.01 mg/kg by intravenous route . Intraoperative mean arterial blood pressure and heart rate will be recorded immediately after induction , at incision time and every 5 mins till the end of the procedure .
Any incidence of oculocardiac reflex will be recorded regarding its onset and time of occurrence and the associated or causing manipulations along with recording of the way the reflex had been dealt with and any given medications or additional blocks required to interfere with the oculocardiac reflex. Any change in the heart rate more than 20 % than the baseline heart rate will be treated by asking the surgeon to stop and if that interference wasn't efficient, an intravenous dose of Atropine of 0.01 mg/kg will be given to the patients and also the dosing of given Atropine will be recorded. After end of the surgery and discontinuation of anesthesia, patients will be transferred to PACU and observed for about 2 hours in the PACU before discharging them to their wards, immediately after discharge and then every 15 mins with total post-operative evaluation time of 6 hours.
Post-operative recovery will be evaluated by using Aldrete score. The post-operative pain will be assessed by using the VAS scale and it will be assessed every 15 mins and any post-operative pain will be recorded , paracetamol will be given regularly in a dose of 15 mg/ kg every 6-8 hours any additional analgesia will be given to the patient if the vas scale \> 3 e.g. NSAIDS will be recorded .
Cases with persistent post-operative emesis will be dealt with by appropriate anti-emetic drugs and recorded. Any complications regarding the Peribulbar block (Hemorrhage, Hematoma, etc.) will be recorded.
- Conditions
- Pediatric Squint Surgeries
- Being tested
- Articaine and Epinephrine Only Product, levobupivacaine, mepivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine and Epinephrine Only ProductDrug
comparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and postoperative pain in pediatrics undergoing squint surgeries with general anesthesia
levobupivacaineDrug
comparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and postoperative pain in pediatrics undergoing squint surgeries with general anesthesia
mepivacaineDrug
comparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and in peribulbar block on postoperative pain in pediatrics undergoing squint surgeries with general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| For group A | Experimental | Group A will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Articaine 4 % with adrenaline 1/100000 mixed with 10IU of Hyaluronidase by a single injection technique: a 26/27 gauge needle will be inserted as far laterally as possible in the inferotemporal quadrant. Once the needle is under the globe, it will be directed along the orbital floor, passing the globe equator to a depth controlled by observing the needle/hub junction reaching the plane of the iris. After negative aspiration for blood, with the globe in primary gaze, and start injection and the injected volume will be guided by digital intraocular pressure. Receives: Drug: Articaine and Epinephrine Only Product |
| Group L | Experimental | General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Lidocaine 2%mixed with 10IU of Hyaluronidase by a single injection technique. Receives: Drug: levobupivacaine |
| Group M | Experimental | General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml (according to the volume of the eye) of Mepivacaine 3% mixed with 10IU of Hyaluronidase by a single injection technique. Receives: Drug: mepivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Intraoperative oculocardiac reflex.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start22 Feb 2022
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Squint SurgeriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abeer Salem, MD, Principal investigator, Research Institute of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728151
- Sponsor's protocol ID
- RIO2022
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2023
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing General Anesthesia With Single Injection Peribulbar Block With Articaine 4% vs Lidocaine 2% vs Mepivacaine 3 % for Prevention of Oculocardiac Reflex in Children Undergoing Strabismus Surgery : A Randomized Control Study
- ClinicalTrials.gov ID
- NCT05728151
- Acronym / sponsor ID
- RIO2022
- Conditions
- Pediatric Squint Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 14 Feb 2023 (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.
To compare the effect of the used local anesthetics in this study on decreasing the incidence of oculocardiac reflex . To evaluate the efficacy of Articaine 4 % , mepivacaine 3% and lidocaine 2% regarding post- operative analgesia.
Detailed description
Population of study: Children undergoing strabismus surgery aged from 7 to 14 years .
- 55 participants grouped randomly into 3 groups :
- Group A :will receive General Anesthesia combined with Peribulbar Block with 5ml of Articaine 4% with 1/100000 adrenaline and 10 International Units (IU) of Hyaluronidase .
- Group L :will receive General Anesthesia combined with Peribulbar Block with 5ml of Lidocaine 2% and 10 IU of Hyaluronidase .
- Group M : will receive General Anesthesia combined with Peribulbar Block with 5 ml of mepivacaine 3% and 10 IU of Hyaluronidase
- Methodology in details:
After obtaining informed written consent from the parents of children after explaining the procedure to them, random allocation of patients into three groups will be done.
In all groups: upon arrival to the operating room, preoperative sedatives in the form of midazolam 0.05 mg/kg by Intravenous route will be used ,standard monitor including; electrocardiogram (ECG), non-invasive blood pressure and pulse oximeter were attached to the patients. The induction of anesthesia will be by intravenous route .
Insertion of 24-22 Gauge Intravenous (IV) catheter and appropriate size laryngeal mask airway (LMA) will be inserted . Anesthesia will be maintained using 100% oxygen and sevoflurane with spontaneous respiration and capnogram will be attached to obtain continuous measurement of end-tidal carbon dioxide (ETCO2).
For group A : General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Articaine 4 % with adrenaline 1/100000 mixed with 10IU of Hyaluronidase by a single injection technique: a 26/27 gauge needle will be inserted as far laterally as possible in the inferotemporal quadrant. Once the needle is under the globe, it will be directed along the orbital floor, passing the globe equator to a depth controlled by observing the needle/hub junction reaching the plane of the iris. After negative aspiration for blood, with the globe in primary gaze, and start injection and the injected volume will be guided by digital intraocular pressure. For Group L : General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Lidocaine 2%mixed with 10IU of Hyaluronidase by a single injection technique. For group M: General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml (according to the volume of the eye) of Mepivacaine 3% mixed with 10IU of Hyaluronidase by a single injection technique. In all of the three groups Intraoperative continuous monitoring with electrocardiography monitor, pulse oximeter and Capnography will be done, and adequate hydration will be taken care of with IV fluid ringer lactate until the oral intake is allowed. In all Groups :monitoring for the incidence of Oculocardiac reflex will be done within (2-3) mins after induction of general anesthesia and giving the Peribulbar Block which is the time of required for draping and sterilization of the eye, there will be intraoperative monitoring for the incidence of Oculocardiac reflex during eye manipulations , good attention for the depth of anesthesia, any rise or drop in the Heart Rate or the Blood Pressure . Intraoperative analgesics using Fentanyl in a dose of 1 mcg/kg will be given intravenously to the patients.
Prophylaxis against post-operative vomiting will be done using Granisterone in a dose of 0.01 mg/kg by intravenous route . Intraoperative mean arterial blood pressure and heart rate will be recorded immediately after induction , at incision time and every 5 mins till the end of the procedure .
Any incidence of oculocardiac reflex will be recorded regarding its onset and time of occurrence and the associated or causing manipulations along with recording of the way the reflex had been dealt with and any given medications or additional blocks required to interfere with the oculocardiac reflex. Any change in the heart rate more than 20 % than the baseline heart rate will be treated by asking the surgeon to stop and if that interference wasn't efficient, an intravenous dose of Atropine of 0.01 mg/kg will be given to the patients and also the dosing of given Atropine will be recorded. After end of the surgery and discontinuation of anesthesia, patients will be transferred to PACU and observed for about 2 hours in the PACU before discharging them to their wards, immediately after discharge and then every 15 mins with total post-operative evaluation time of 6 hours.
Post-operative recovery will be evaluated by using Aldrete score. The post-operative pain will be assessed by using the VAS scale and it will be assessed every 15 mins and any post-operative pain will be recorded , paracetamol will be given regularly in a dose of 15 mg/ kg every 6-8 hours any additional analgesia will be given to the patient if the vas scale \> 3 e.g. NSAIDS will be recorded .
Cases with persistent post-operative emesis will be dealt with by appropriate anti-emetic drugs and recorded. Any complications regarding the Peribulbar block (Hemorrhage, Hematoma, etc.) will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| For group A | Experimental | Drug: Articaine and Epinephrine Only ProductGroup A will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Articaine 4 % with adrenaline 1/100000 mixed with 10IU of Hyaluronidase by a single injection technique: a 26/27 gauge needle will be inserted as far laterally as possible in the inferotemporal quadrant. Once the needle is under the globe, it will be directed along the orbital floor, passing the globe equator to a depth controlled by observing the needle/hub junction reaching the plane of the iris. After negative aspiration for blood, with the globe in primary gaze, and start injection and the injected volume will be guided by digital intraocular pressure. |
| Group L | Experimental | Drug: levobupivacaineGeneral Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Lidocaine 2%mixed with 10IU of Hyaluronidase by a single injection technique. |
| Group M | Experimental | Drug: mepivacaineGeneral Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml (according to the volume of the eye) of Mepivacaine 3% mixed with 10IU of Hyaluronidase by a single injection technique. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with ASA I , II.
- Age from 7 to 14 years old.
- Patients undergoing Strabismus Surgery
Key exclusion criteria (6 listed)
- Patients with ASA III ,IV.
- Patients with Endophthalmitis , orbital fractures.
- Any Congenital or Cardiac anomalies.
- Patients with history of allergy to local anesthetics.
- Revision Surgeries.
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 |
|---|---|---|
| Articaine and Epinephrine Only Productcomparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and postoperative pain in pediatrics undergoing squint surgeries with general anesthesia | Drug | For group A |
| levobupivacainecomparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and postoperative pain in pediatrics undergoing squint surgeries with general anesthesia | Drug | Group L |
| mepivacainecomparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and in peribulbar block on postoperative pain in pediatrics undergoing squint surgeries with general anesthesia | Drug | Group M |
Primary outcome
The incidence of Intraoperative oculocardiac reflex.
Time frame: intraoperative
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 23 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Pediatric Squint Surgeries
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Postoperative Vomiting, Postoperative Nausea and Vomiting
Not yet recruitingPhase 3
A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
Esotropia
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.
Abeer Salem, MD principal investigator
Research Institute of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articaine and Epinephrine Only Product, levobupivacaine and mepivacaine in people with Pediatric Squint Surgeries, run by Research Institute of Ophthalmology, Egypt 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 3 inclusion and 6 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 23 Apr 2025. 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?
The incidence of Intraoperative oculocardiac reflex. (time frame: intraoperative). 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 23 Apr 2025.