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

Cairo University (CU)

Status and phase: Unknown; Early Phase 1

Conditions: Suprazygomatic Maxillary Nerve Block

Treatments: Other: UG-SZM Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05023239

n-2021

Details and patient eligibility

About

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 .

Enrollment: 52 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

control group

Sham Comparator group

Description:

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

Treatment:

Other: UG-SZM Group

UG-SZM Group

Experimental group

Description:

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

Treatment:

Other: UG-SZM Group