Comparing General Anesthesia With Single Injection Peribulbar Block With 3 Different Drugs

NCT05728151 | Completed

• 1 other identifier: RIO2022
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Squint Surgeries

Outcome Measures

Primary Outcomes (1)

• The incidence of Intraoperative oculocardiac reflex.

  intraoperative

Study Arms (3)

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.

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.

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.

Drug: mepivacaine

Interventions

Articaine and Epinephrine Only Product DRUG

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

For group A

levobupivacaine DRUG

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

Group L

mepivacaine DRUG

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

Group M

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with ASA I , II.
• Age from 7 to 14 years old.
• Patients undergoing Strabismus Surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Institute of Ophthalmology, Egypt: lead

Study Sites (1)

Research Institute of Ophthalmology

Giza, 12611, Egypt

Location

MeSH Terms

Interventions

Carticaine; Levobupivacaine; Mepivacaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bupivacaine; Anilides; Amides; Aniline Compounds; Amines; Piperidines

Study Officials

• Abeer Salem, MD

  Research Institute of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 14, 2023
• Study Start: February 22, 2022
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: April 23, 2025

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)