An interventional study of peribulbar block and sub-tenon block in Anesthesia, Local, Ophthalmopathy and Strabismus, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
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.
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
142 studies on the registry are indexed under Strabismus; 31 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 82 interventional studies indexed under Strabismus.
Browse Strabismus studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Strabismus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Eye Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 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.
Procedure: peribulbar block
Children 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.
Procedure: sub-tenon block
Children in the paracetamol group received IV paracetamol (15 mg/kg) after induction of anesthesia before any surgical intervention.
Drug: Paracetamol
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
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.
Children in the control group received IV paracetamol (15 mg/kg) after induction of anesthesia before any surgical intervention.
Also known as: paracetamol iv
The incidence of intraoperative oculocardiac reflex (OCR)
drop in heart rate below 60 bpm
Time frame: 2 hours
blood pressure
blood pressure in mmhg will be recorded preop, after induction, and every 15 minutes.
Time frame: 2 hours
heart rate
heart rate as beats per minute will be recorded preop, after induction, and every 15 minutes.
Time frame: 2 hours
Post-operative pain using the MOPS
pain assessed using the MOPS
Time frame: 4 hours
Post-operative analgesia requirements
pethidine 0.5 mg/kg was administered IV
Time frame: 4 hours
The incidence of POV using numeric scoring
using Numeric scoring at 30 minutes and 2h post-operative
Time frame: 2 hours
Complications resulting from orbital regional anesthesia were recorded
e.g.: subconjunctival hemorrhage, local anesthetic toxicity, chemosis, optic neuropathy, extra-ocular muscle paresis
Time frame: 2 hours
Total intraoperative atropine requirements
Brady arrhythmias intraoperatively which are the most common presentation of OCR was considered when an acute decrease in heart rate below 60 beats/min and was treated by asking the surgeon to stop stimulation and giving intravenous atropine (0.01 mg. kg)
Time frame: 2 hours
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