Health TrialsbyHealthPanel

Glossopharyngeal and Maxillary Nerve Blocks in Adenotonsillectomy

ConditionsRegionalAdenotonsillectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pediatric patients aged 5 to 13 years

American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy.

Disqualifiers

Parents Refusal

Cognitive impairment or developmental delays.

Infection at injection site.

Recent upper respiratory tract infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound-guided glossopharyngeal nerve block (UGSGNB)

    Procedure/Surgery

    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.

  • ultrasound-guided maxillary nerve (UGMN)

    Procedure/Surgery

    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.

  • Placebo Block

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Block GroupActive comparator 2 interventions
Group B: Conventional GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first rescue analgesia

Time of the first claim for analgesia

Time frame
24 hours

Secondary outcomes

1

Heart rate

Intraoperative monitoring of heart rate measured beats/minute

Time frame
2 hours
2

Intraoperative fentanyl consumption

Intraoperative fentanyl consumption in microgram

Time frame
2 hours
3

Dietary intake

Dietary intake on post operative day 1 will be evaluated on a 5-point Likert scale (0 = no food intake; 5 = complete meals) at each meal by the ward nurse

Time frame
24 hours
4

Postoperative pain scores

Postoperative pain scores every 2, 4, 8, 12, and 24 hours postoperative after transferring to the ward. Quality of analgesia will be assessed using Wong-Baker FACES scale for children more than 3 years of age up to 8 years of age and Visual Analogue Scale for older children every 30 minutes for 1 hour after recovery from anesthesia in PACU and every 2, 4, 8, 12, and 24 hours postoperative after transferring to ward.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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