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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Research Institute of Ophthalmology

    Giza, 12611

Other trials in Egypt

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.

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 groups in NCT05728151
Study groupRoleWhat they receive
For group AExperimentalGroup 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 LExperimentalGeneral 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 MExperimentalGeneral 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.

  1. 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.

  1. First posted14 Feb 2023
  2. Study start22 Feb 2022
  3. Primary completion18 Apr 2024
  4. Study completion18 Apr 2024

Resources

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)
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

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.

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