Dexamethasone as Adjuvant to Bupivacaine in Suprazygomatic Maxillary Nerve Block

NCT05530811 | Unknown

• 1 other identifier: suprazygomatic maxillary nerve
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC) is the primary outcome. The secondary outcomes are the first-time requested analgesia, the number of children required analgesia, the total amount of analgesic requirements during first the 24 hours.

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (2)

• Postoperative pain score

  pain in Faces, Legs, Activity, Cry, Consolability (FLACC) Each category is scored on the 0-2 scale which results in a total score of 0-10.

  baseline

• Assessment of Behavioral Score

  0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

  baseline

Secondary Outcomes (3)

• The first-time requested analgesia .

  24 hours

• The number of children required analgesia.

  24 hours

• The total amount of analgesic requirements .

  24 hours

Study Arms (2)

with dexamethasone

ACTIVE COMPARATOR

bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline.

Drug: Dexamethasone; Drug: Bupivacaine

without dexamethasone

PLACEBO COMPARATOR

bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine alone and diluted to 2 mL with 0.9% saline.

Drug: Bupivacaine

Interventions

Dexamethasone DRUG

The suprazygomatic maxillary nerve block approach will be performed with a 27-gauge 38-mm needle following aseptic preparation of the skin and using the anatomical landmarks. The puncture site will be at the frontozygomatic angle formed by the zygomatic arch and posterior orbital rim. After inserting the needle perpendicular to the skin and contacting the greater wing of the sphenoid (approximately 20 mm deep), the needle will be partially withdrawn, reoriented approximately 20° anterior and 10° inferior, and advanced 35 to 38 mm to direct the needle into the pterygopalatine fossa. After negative blood aspiration, the prepared solution will be injected over 20 s on each side. Massage of injection point with pressure for 2 min will be done. No additional local anesthetic will be injected by the surgeon either peri-incisional or submucosal.

with dexamethasone

Bupivacaine DRUG

0.5% bupivacaine

with dexamethasone; without dexamethasone

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 1 and 9 years
• Children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts
• Gender: both
• ASA grade I - II.
• Informed consent.

You may not qualify if:

• Parent refusal
• History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
• Hypersensitivity to any local anesthetics
• Bleeding diathesis
• Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders
• Skin lesions or wounds at the puncture site of the proposed block

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexamethasone; Bupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mark W, Debais, resident

CONTACT

+201032090320; drmarkwageh@gmail.com

Mohammed M. Abdel-latef, professor

CONTACT

+201001745301; latif_mohamed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesia and ICU Resident

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: September 7, 2022
• Study Start: April 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-02