Glossopharyngeal and Maxillary Nerve Blocks in Adenotonsillectomy

NCT07379866 | Recruiting

• 2 other identifiers: MS-389-2025University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare of bilateral ultrasound-guided glossopharyngeal nerve (UGGNB) and ultrasound-guided maxillary nerve (UGMNB) versus conventional multimodal analgesia for tonsillectomy operations.

Conditions

Regional; Adenotonsillectomy

Keywords

Ultrasound; Glossopharyngeal; Adenotonsillectomy; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia

  Time of the first claim for analgesia

  24 hours

Secondary Outcomes (7)

• Heart rate

  2 hours

• Intraoperative fentanyl consumption

  2 hours

• Dietary intake

  24 hours

• Postoperative pain scores

  24 hours

• Total pethidine requirements

  24 hours

Study Arms (2)

Block Group

ACTIVE COMPARATOR

patients will receive combined bilateral ultrasound-guided glossopharyngeal nerve (UGGNB) and bilateral ultrasound-guided maxillary nerve (UGMNB) immediately after the induction of anesthesia and prior to surgical incision

Procedure: ultrasound-guided glossopharyngeal nerve block (UGSGNB); Procedure: ultrasound-guided maxillary nerve (UGMN)

Conventional Group

PLACEBO COMPARATOR

patients will receive multimodal analgesia for tonsillectomy operations in the form of single dose of IV paracetamol 15 mg/kg

Procedure: Placebo Block

Interventions

ultrasound-guided glossopharyngeal nerve block (UGSGNB) PROCEDURE

For the procedure, anesthesiologist will turn patient face carefully toward the clinician, and a linear ultrasound probe will be placed in the neck to check the surrounding target structures: the sternocleidomastoid muscle, the common carotid artery, and the internal jugular vein. After the sternocleidomastoid muscle has been identified, a linear ultrasound probe will be placed parallel to sternocleidomastoid muscle fiber direction just caudal to the mandibular ramus. The stylohyoid muscle is easily visualized by tiling the linear ultrasound probe toward the mandibular ramus. In this area, the stylohyoid muscle is positioned under the sternocleidomastoid muscle, and both can be observed under ultrasound guidance. A 25-gauge, 25-mm needle will be inserted deeply under the stylohyoid muscle through the sternocleidomastoid muscle via an out-of-plane approach. An ultrasound-guided nerve block will be performed with 3 mL of 0.25% bupivacaine after the absence of blood backflow is confirmed.

Block Group

ultrasound-guided maxillary nerve (UGMN) PROCEDURE

Curvilinear ultrasound probe will be placed in infra-zygomatic area, over maxilla, angled 45° cephalad. This probe position allows visualization of pterygopalatine fossa, limited anteriorly by maxilla and posteriorly by greater wing of sphenoid. A 22- gauge, 5-cm needle will be inserted perpendicularly to the skin following aseptic preparation of the skin at the frontozygomatic angle formed by posterior orbital rim and zygomatic. Once contact was made with the greater wing of sphenoid, needle will be redirected caudally and medially, and advances through the pterygomaxillary fissure into pterygomaxillary fossa. needle will be advanced using an out-of-plane approach, and needle tip can usually be identified during movements. Needle placement will be verified by real-time ultrasound guidance and negative aspiration before administration of 3-4 ml of 0.25 % bupivacaine. The same procedure will be then repeated on the contralateral side.

Block Group

Placebo Block PROCEDURE

ultrasound-guided maxillary nerve (UGMN) and ultrasound-guided glossopharyngeal nerve block (UGSGNB) using normal saline as placebo effect

Conventional Group

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged 5 to 13 years
• American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy.

You may not qualify if:

• Parents Refusal
• Cognitive impairment or developmental delays.
• Infection at injection site.
• Recent upper respiratory tract infection.
• Post-tonsillectomy bleeding, allergy to local anesthetics.
• American Society of Anesthesiologists (ASA) class III and IV.
• Morbid obesity.
• Those receiving regular analgesia within the last week before surgery.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Governorate, 002, Egypt

RECRUITING

Study Officials

• Nagy malak, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagy Malak, MD

CONTACT

+201552480258; nagymalak12345@gmail.com

Atef Salama, MD

CONTACT

01001155851; atef.kamel@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. The study will be a single blinded trial where the assessor who follow the patients post-operatively is blinded to the technique given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will receive combined bilateral ultrasound-guided glossopharyngeal nerve (UGGNB) and bilateral ultrasound-guided maxillary nerve (UGMNB) immediately after the induction of anesthesia and prior to surgical incision by an expert anesthesiologist in ultrasound guided regional anesthesia who is not a part of the study using Philips Model HD5 Diagnostic ultrasound system a the scanning probe will be the linear ultrasound probe (4-12MHz) for glossopharyngeal nerve block and a curvilinear ultrasound probe (5-7 MHz) for maxillary nerve block using fine needle as described with aid of ultrasound.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 2, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)