Ultrasound-Guided Suprazygomatic Maxillary Nerve Block as A Part of Multimodal Analgesic Regimens

NCT ID: NCT05023239

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-12-01

Brief Summary

Inadequate peri-operative analgesia may contribute to an increased risk of bleeding, suture dehiscence and unacceptable surgical outcomes. Moreover, these patients are at high risk of postoperative airway obstruction and respiratory failure.

Opioids may contribute to these complications. Appropriate use of regional anaesthesia may mitigate or eliminate many of these concerns. The maxillary nerve is responsible for the sensory innervation of the midface, including the hard and soft palates, upper jaw, upper dental arch and upper lip.Recently, the successful use of maxillary nerve block by the suprazygomatic approach has been reported in children undergoing cleft palate surgery. However, the use of this block has not been described in large series of patients, and the effectiveness of the suprazygomatic approach has not been evaluated in patients undergoing tonsillectomy .

Conditions

Suprazygomatic Maxillary Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

control group

patients will receive sham block by 10 ml of normal saline (5 mL in each side) as a control.

Group Type: SHAM_COMPARATOR

UG-SZM Group

Intervention Type: OTHER

The patients will be receive Ultrasound-Guided Suprazygomatic Maxillary Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine .

UG-SZM Group

The patients will be receive bilateral Ultrasound-Guided Suprazygomatic Maxillary (UG-SZM) Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine

Group Type: EXPERIMENTAL

UG-SZM Group

Intervention Type: OTHER

The patients will be receive Ultrasound-Guided Suprazygomatic Maxillary Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine .

Interventions

UG-SZM Group

The patients will be receive Ultrasound-Guided Suprazygomatic Maxillary Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine .

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Pediatric patients aged 4-12 years

2. Genders eligible for study: both sexes

3. ASA physical status I and II

4. Undergoing tonsillectomy surgery

Exclusion Criteria

• Parents' refusal
• Contraindications to regional anesthesia
• Known allergy to local anesthetics
• Bleeding disorders
• Children with diabetes mellitus, obstructive sleep apnea syndrome, cardiac, renal, liver or blood diseases, swallowing disorders or peritonsillar abscess,
• Children receiving regular analgesia within the last week before surgery,
• Children undergoing simultaneous procedure in the field of surgery like adenoidectomy or tongue tie will be all excluded from the study.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

amr wahdan, MD

Role: CONTACT

amr_amw010@hotmail.com

01001422499

Other Identifiers

n-2021

Identifier Type: -

Identifier Source: org_study_id