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

NCT06293586 | Recruiting

• 1 other identifier: MD-11-2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique.

Conditions

Anesthesia, Local; Ophthalmopathy; Strabismus; Pediatric ALL

Keywords

paracetamol; peribulbar block; sub-tenon block; pediatric strabismus surgery; oculocardiac reflex

Outcome Measures

Primary Outcomes (1)

• The incidence of intraoperative oculocardiac reflex (OCR)

  drop in heart rate below 60 bpm

  2 hours

Secondary Outcomes (2)

• blood pressure

  2 hours

• heart rate

  2 hours

Other Outcomes (5)

• Post-operative pain using the MOPS

  4 hours

• Post-operative analgesia requirements

  4 hours

• The incidence of POV using numeric scoring

  2 hours

Study Arms (3)

Peribulbar group (Group P)

EXPERIMENTAL

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

sub-tenon group (group S)

EXPERIMENTAL

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

paracetamol (group C)

ACTIVE COMPARATOR

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

Drug: Paracetamol

Interventions

peribulbar block PROCEDURE

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

Peribulbar group (Group P)

sub-tenon block PROCEDURE

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.

sub-tenon group (group S)

Paracetamol DRUG

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

Also known as: paracetamol iv

paracetamol (group C)

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University faculty of medicine

Cairo, 11559, Egypt

RECRUITING

MeSH Terms

Conditions

Eye Diseases; Strabismus; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Essam Nossair, Masters

CONTACT

0201002014809; e.nossair92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 5, 2024
• Study Start: December 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Locations

EG (1)