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

NCT ID: NCT06694077

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-06-01

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.

Detailed Description

This study is about the Analgesic Effect of Suprazygomatic Maxillary Nerve Block with and without Dexamethasone in Pediatric Adenotonsillectomy: A Randomized Double-Blinded Clinical Trial," investigates the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain management in children undergoing adenotonsillectomy. Adenotonsillectomy, a frequent surgical procedure in pediatric patients to address chronic infections and airway obstruction, is commonly associated with significant postoperative pain due to thermal and mechanical injury to tissues. This injury triggers inflammation, muscle spasms, and nerve irritation, which can lead to severe discomfort, decreased oral intake, and potential complications like dehydration.

The tonsils are primarily innervated by the maxillary division of the trigeminal nerve and the glossopharyngeal nerve, while the adenoids are innervated by branches of the trigeminal nerve alone. Despite traditional systemic analgesics being standard in pain management for such cases, they may not always provide adequate relief and can introduce undesirable side effects, particularly in pediatric patients. This limitation has spurred interest in regional anesthesia techniques, such as the suprazygomatic maxillary nerve block, which has been used in various facial and dental procedures but is less common in adenotonsillectomy. Combining dexamethasone, a potent corticosteroid known for its anti-inflammatory properties, with local anesthetics could provide enhanced analgesia and prolong the block's duration, potentially reducing the need for additional opioids post-surgery.

This randomized, double-blind, controlled clinical trial will be conducted at the ENT Operating Theatre at Assiut University Hospitals. The study will involve 80 pediatric patients between 3 and 10 years old, classified as ASA physical status I or II, who are scheduled for adenotonsillectomy. Participants will be randomized into two groups of 40 each: Group A will receive a suprazygomatic maxillary nerve block with 0.5% bupivacaine combined with dexamethasone, and Group B will receive the same nerve block with bupivacaine alone.

For statistical analysis, data will be verified, coded, and processed using IBM-SPSS 24.0 software. Mean and standard ddeviations will be calculated for normally distributed variables, and a two-way repeated measures ANOVA will be used to analyze pain score trends over time. A significance level of p<0.05 will be used for all analyses.

Ultimately, this study aims to establish whether adding dexamethasone to the suprazygomatic maxillary nerve block could enhance pain control, reduce the need for systemic analgesics, and improve overall recovery outcomes for pediatric patients undergoing adenotonsillectomy. Positive findings may position this combination as a safer, more effective pain management strategy, potentially improving the postoperative experience and outcomes in pediatric surgeries

Conditions

Tonsillectomy Postoperative Adverse Events; Dexamethasone Administration; Bupivacaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bupivacaine with Dexamethasone

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.

Group Type: EXPERIMENTAL

Bupivacaine with Dexamethasone

Intervention Type: 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 only

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

Group Type: EXPERIMENTAL

Bupivacaine only

Intervention Type: 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

Interventions

Bupivacaine with Dexamethasone

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.

Intervention Type: DRUG

Bupivacaine only

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abanoub saad kamal kamel

Resident at anaesthesia and icu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Saad Kamal

Role: CONTACT

abanoubsaad84.6@gmail.com

+2001202626697

Other Identifiers

04-2024-200938

Identifier Type: -

Identifier Source: org_study_id