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Anesthesia, LocalNCT06293586

Comparison Between Peribulbar And Sub-tenon Blocks on Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery

A study testing peribulbar block, sub-tenon block and Paracetamol in people with Anesthesia, Local and Ophthalmopathy, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Read more about this study

Who is it for?
Ages 6 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia, Local, Ophthalmopathy, Strabismus
What is being tested?
peribulbar block, sub-tenon block and Paracetamol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 30 Mar 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 6 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Participants were children (6-13 years), ASA I-II patients, scheduled to undergo strabismus surgery.

Who cannot join

  • Children with tumors or infections of the orbit, raised intraocular pressure more than 20 mm Hg, axial length more than 28 mm, eye injury, airway abnormalities or who were blind in the eye other than that which was to be operated on were excluded. Other exclusion criteria included patients undergoing revision surgery, known allergy to local anesthetics or non-steroidal antiinflammatory drugs (NSAIDs), steroid therapy, parental refusal to participate and patients with INR more than 1.5 or with platelets less than 100.

Trial locations and contacts

1 site in 1 country.

Essam Nossair, Masters contact

0201002014809

e.nossair92@gmail.com

Egypt1 site, 1 recruiting
  • Cairo University faculty of medicine

    Cairo, 11559

    Essam Nossair, Masters degree, 0201002014809, e.nossair92@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: A Comparison Between The Effects Of Peribulbar And Sub-tenon Blocks Combined With General Anesthesia On The Incidence Of Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery: A Double Blinded Randomised Control Study

The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique.

Read the detailed description

120 children, American Society of Anaesthesiology (ASA) I or II, aged 6 to 13 years, scheduled for elective squint surgery under GA will be included in the study. Children with tumors or infections of the orbit, raised intraocular pressure, eye injury, airway abnormalities or who are blind in the eye other than that which will to be operated, will be excluded. Other exclusion criteria will include known allergy to local anaesthetics or nonsteroidal anti-inflammatory drugs (NSAIDS), steroid therapy, those with significant cardiac, respiratory, renal, hepatic, or neurological disorders, mentally challenged children, or parental refusal to participate.

All children will undergo a detailed preanesthetic evaluation including previous history of operations, drug history, physical examination (cardiovascular and respiratory systems, blood pressure, oxygen saturation, airway and dentition, body weight and height). During the pre-anesthesia evaluation, children will be encouraged to report postoperative pain, if present. All children will be fasted for a minimum of 4 hours and premedicated with oral midazolam 0.5 mg/kg 30 minutes before anaesthesia. Anesthesia will be induced with sevoflurane 6% in oxygen or intravenous (i.v.) propofol (2mg/kg), as appropriate for the child's age and preference. Following inhalational induction, an intravenous line will be placed. The airway will be secured using an appropriately sized endotracheal tube (ETT) following intravenous atracurium(0.5 mg.kg) and 1 to 3 min of mask ventilation using isoflurane 1.5% in oxygen.Anesthesia will then be maintained with isoflurane in air-oxygen and end tidal minimal alveolar concentration maintained at 1 to 1.3. ventilation will be established at 6-8ml per kg with a target PECO2 of 32 - 34 and will be adjusted accordingly.

Children will then be randomly allocated to one of three groups; by a nurse who will not participate in the study, reads the number contained in the envelope and makes group assignment.

Children in the control group (group C, n_20) will receive IV paracetamol (20mg/kg).

Children in the sub-tenon group (sub-tenon group (S), n _ 20) will receive a sub-tenon block. Sub-Tenon's anesthesia will be performed with 5% bupivacaine (0.08 ml/kg). Under sterile conditions, a 19-gauge curved, blunt metallic cannula (25 mm) will be inserted into sub-Tenon's space and the local anesthetic will be injected by the ophthalmologist.

The peribulbar group (P group _ 20) will receive peribulbar block with 0.25 mL/kg of a 1:1 mixture of 0.5% bupivacaine and 2% lignocaine containing hyaluronidase (500 IU hyaluronidase has been premixed with 30 mL 2% lignocaine). Peribulbar block using a two-injection technique will be performed by a second anaesthetist.

The children will not be aware to as which group they will be allocated into. Digital oculopression will be performed for 5 minutes. All blocks will be performed by one of the investigators. LAM will be injected both inferotemporallly and superonasally using a 26-G needle. Haemodynamic variables; electrocardiography (ECG), pulse oximetry, noninvasive blood pressure (NIBP) and end tidal carbon dioxide (PECO2); will be monitored continuously and Occurrence of oculocardiac reflex (OCR) will be recorded (either in the form of bradyarrhythmias mostly sinus bradycardia or o) . bradyarrhythmias which is the most common presentation of Oculocardiac reflex (OCR) will be considered as an acute decrease in heart rate below 60 beats/min and will be treated by asking the surgeon to stop stimulation and giving intravenous atropine (0.01 mg.kg), whereas other less common presentations of oculocardiac reflex (OCR) will be managed accordingly. All children will receive Dexamethasone (0.125mg/kg) 30 minutes before the end of surgery. At the end of the procedure, the ETT will be removed after reversing residual neuromuscular blockade with 50 μg·kg-1 neostigmine and 20 μg·kg-1 atropine and adequate spontaneous ventilation established.

Children will then be transferred to the recovery room, where they will be kept for 2 to 3 hours. On arrival in the recovery room, the child's' behavior and postoperative pain level will be assessed at 30 min by the recovery room nurse who will not be aware of the block using the modified objective pain scale (MOPS) [10] which assess pain via 5 points (crying, facial expressions, posture of the trunk, posture of the legs, and motor restlessness) with a minimum score of 0 and a maximum score of 10. 0-1 (no pain), 2-5 (mild), 6-7 (moderate), and 8-10 (severe) out of 10.

For pain judged as moderate or severe (MOPS > 5), ibuprofen 10mg/kg will be administered orally. After 2 hours in the recovery area, the children's pain will be assessed by Modified objective pain scale (MOPs) at 2 and 4 hours. Requirement of postoperative analgesia will be recorded. The incidence of PONV will be recorded. Numeric scoring will be used for PONV (0 = no nausea; 1 = nausea is present, but no vomiting; 3 = vomiting once within 30 min; 4 = vomiting two or more times within 30 min). Ondansetron (0.1 mg/kg, i.v.) will be given in cases of vomiting. The data collector will not be aware of the intervention the child will receive

Being tested
peribulbar block, sub-tenon block, Paracetamol
Keywords
paracetamol, peribulbar block, sub-tenon block, pediatric strabismus surgery, oculocardiac reflex
Medical subject headings
Eye Diseases, Strabismus, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peribulbar blockProcedure or surgery

    Peribulbar block using a two-injection technique was performed by a second anesthetist under sterile conditions and before the application of surgical drapes. LAM was injected both infratemporal and superonasally using a 26-G needle, in contrast to the single infratemporal injection approach.

    Gentle digital oculopression was performed for 5 minutes

  • sub-tenon blockProcedure or surgery

    Children in the sub-Tenon group received a sub-Tenon block. Sub-Tenon's anesthesia was performed with 0.5% bupivacaine (0.08 ml/kg), bearing in mind not to exceed the maximum dose. Under sterile conditions, a 19- gauge curved blunt metallic cannula (25 mm) was inserted into sub-Tenon's space and the local anesthetic was injected by the ophthalmologist after the application of surgical drapes.

  • ParacetamolDrug

    Also called paracetamol iv

    Children in the control group received IV paracetamol (15 mg/kg) after induction of anesthesia before any surgical intervention.

Study groups in NCT06293586
Study groupRoleWhat they receive
Peribulbar group (Group P)ExperimentalThe peribulbar group (P group _ 40) received a peribulbar block with 0.25 mL/kg of a 1:1 local anesthetic mixture (LAM) of 0.5% bupivacaine and 2% lignocaine. Peribulbar block using a two-injection technique was performed by a second anesthetist under sterile conditions and before the application of surgical drapes. LAM was injected both infratemporal and superonasally using a 26-G needle, in contrast to the single infratemporal injection approach.
Receives: Procedure: peribulbar block
sub-tenon group (group S)ExperimentalChildren in the sub-Tenon group (sub-Tenon group (S), n _ 40) received a sub-Tenon block. Sub-Tenon's anesthesia was performed with 0.5% bupivacaine (0.08 ml/kg), bearing in mind not to exceed the maximum dose. Under sterile conditions, a 19- gauge curved blunt metallic cannula (25 mm) was inserted into sub-Tenon's space and the local anesthetic was injected by the ophthalmologist after the application of surgical drapes.
Receives: Procedure: sub-tenon block
paracetamol (group C)Active comparatorChildren in the paracetamol group received IV paracetamol (15 mg/kg) after induction of anesthesia before any surgical intervention.
Receives: Drug: Paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of intraoperative oculocardiac reflex (OCR)

    drop in heart rate below 60 bpm

    Measured: 2 hours

Secondary outcomes (2)
  1. blood pressure

    blood pressure in mmhg will be recorded preop, after induction, and every 15 minutes.

    Measured: 2 hours

  2. heart rate

    heart rate as beats per minute will be recorded preop, after induction, and every 15 minutes.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start1 Dec 2023
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion30 Mar 2024 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06293586
Sponsor's protocol ID
MD-11-2022
Status last verified
Feb 2024
First submitted
20 Feb 2024
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing peribulbar block, sub-tenon block and Paracetamol in people with Anesthesia, Local and Ophthalmopathy, run by Cairo University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Essam Nossair, Masters (0201002014809, e.nossair92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of intraoperative oculocardiac reflex (OCR) (time frame: 2 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 5 Mar 2024.

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