Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Adenotonsillectomy Patients

NCT06694077 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 04-2024-200938
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study explores the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain relief in children undergoing adenotonsillectomy. The procedure, often performed to address recurrent infections and airway obstruction, results in significant pain due to inflammation and nerve irtypicallyritation. Traditional pain management methods, such as systemic analgesics, may be inadequate or lead to side effects in children. By combining dexamethasone, a potent anti-inflammatory, with local anesthetics, this trial aims to determine if enhanced pain control and a reduction in opioid use can be achieved. The randomized, double-blind clinical trial will involve 80 children aged 3 to 10 years, randomized into two groups: one receiving the nerve block with bupivacaine and dexamethasone, and the other receiving bupivacaine alone. Pain will be assessed postoperatively using the FLACC score, with secondary measures including time to first analgesia, total analgesic use, hemodynamic stability, and any complications. This study aims to demonstrate that the addition of dexamethasone may provide superior pain management in pediatric adenotonsillectomy, offering a safer, opioid-sparing alternative for postoperative care.

Conditions

Tonsillectomy Postoperative Adverse Events; Dexamethasone Administration; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• the total amount of analgesic requirements during first the 24hr after two different blocks.

  Postoperative 24 hours

Secondary Outcomes (1)

• Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC)

  1hour , 2hour, 6hour, 12hour, 24hour

Study Arms (2)

Bupivacaine with Dexamethasone

EXPERIMENTAL

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: Bupivacaine with Dexamethasone

Bupivacaine only

EXPERIMENTAL

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 only

Interventions

Bupivacaine with Dexamethasone DRUG

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.

Bupivacaine with Dexamethasone

Bupivacaine only DRUG

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

Bupivacaine only

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parturient of American Society of Anesthesiologists (ASA) class I or II physical status
• Children scheduled for tonsillectomy with adenoidectomy

You may not qualify if:

• Patient's guardian refusal to participate in the study. Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
• Children on sedative or anticonvulsant medication.
• Bleeding diathesis
• History of sleep apnea
• Significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
• Known allergy to the study drugs.
• Skin lesions or wounds at the puncture site of the proposed block

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Bupivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Saad Kamal

CONTACT

+2001202626697; abanoubsaad84.6@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at anaesthesia and icu

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share