RegionalPediatricsNCT07379866
Glossopharyngeal and Maxillary Nerve Blocks in Adenotonsillectomy
A study testing ultrasound-guided glossopharyngeal nerve block (UGSGNB) and ultrasound-guided maxillary nerve (UGMN) in people with Regional and Adenotonsillectomy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional, Adenotonsillectomy
- What is being tested?
- ultrasound-guided glossopharyngeal nerve block (UGSGNB) and ultrasound-guided maxillary nerve (UGMN)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients aged 5 to 13 years
- American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Cairo, Governorate, 002
Nagy Malak, MD, 01552480258, nagymalak@kasralainy.edu.eg
Atef Salama, MD, 01001155851, atef.kamel@kasralainy.edu.eg
About this study
Official title: Ultrasound Guided Glossopharyngeal and Maxillary Nerve Blocks for Perioperative Pain Control in Adenotonsillectomy in Pediatrics: A Randomized Controlled 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.
Read the detailed description
Patients will be premedicated with oral midazolam 0.5 mg/kg prior to arriving in the operating room 30 min before the procedure.
Standard monitoring will be maintained throughout the procedure included electrocardiography, noninvasive arterial pressure, arterial oxygen saturation.
. If intravenous access is present, Fentanyl 1 μg/kg IV will be given and anesthesia will be induced using propofol 2-3 mg/kg and atracurium 0.5 mg/kg. If intravenous access is not present, anesthesia will be induced with inhalation of 8% sevoflurane in 100% oxygen under spontaneous ventilation and IV access will be established, fentanyl 1 µg/kg IV and atracurium 0.5 m g/kg IV will be given after achieving IV access. Endotracheal intubation will be done using an appropriate size endotracheal tube (ETT) and capnography attached. IV dexamethasone 150 μg/kg will be given. Anesthesia will be maintained using a 50:50 mixture of air and oxygen along with isoflurane 1.2% and the maintenance dose of atracurium 0.1 mg/kg each 20 minutes. Pressure-controlled ventilation and low fresh gas flows will be used. All patients will receive intraoperative analgesia in the form of single dose paracetamol 15 mg/kg.
Patients will be randomly allocated into two equal groups:
Block Group: 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.
Conventional Group: patients will receive multimodal analgesia for tonsillectomy operations in the form of single dose of IV paracetamol 15 mg/kg.
Tonsillectomies will be carried out by expert surgeon using the same electro-dissection surgical technique.
In block group:
Technique of ultrasound-guided glossopharyngeal nerve block (UGSGNB): posterior mandibular ramus approach 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 the 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. The same procedure will be then repeated on the contralateral side.
Technique of ultrasound-guided maxillary nerve (UGMNB): Suprazygomatic maxillary nerve blocks The curvilinear ultrasound probe will be placed in the infrazygomatic area, over the maxilla, angled 45° cephalad. This probe position allows visualization of the pterygopalatine fossa, limited anteriorly by the maxilla and posteriorly by the greater wing of the sphenoid. A 22- gauge, 5-cm nerve block needle will be inserted perpendicularly to the skin following aseptic preparation of the skin at the frontozygomatic angle formed by the posterior orbital rim and zygomatic . Once contact was made with the greater wing of the sphenoid, the needle will be redirected caudally and medially, and advances through the pterygomaxillary fissure into the pterygomaxillary fossa. The needle will be advanced using an out-of-plane approach, and the 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.
In both groups Baseline hemodynamics in the form of: non-invasive BP, HR, oxygen saturation will be recorded before induction of anesthesia. the intraoperative hemodynamics will be recorded at 15 minute intervals in addition to continuous monitoring of HR and oxygen saturation. If heart rate (HR) increases more than 20% of baseline an additional dose of fentanyl 1 µg/kg will be given , if blood pressure exceeding 20% from baseline an additional dose of fentanyl 1 µg/kg will be given with a maximum total dose of 5 mcg/kg if additional doses are required , if bradycardic atropine 0.01 mg/kg will be given. At the end of the surgery , Inhalational anesthesia will be discontinued and muscle relaxation will be reversed by atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) after the restoration of the patient's spontaneous breathing. The patient will be transferred to the post-anesthesia care unit (PACU) for 1 hours to complete recovery and monitoring and then will be sent to the ward. Quality of analgesia will be assessed using the Wong-Baker FACES scale for children more than 3 years of age up to 8 years of age and VAS score for older children every 30 minutes for 1 hours after recovery from anesthesia in PACU and every 2, 4, 8, 12, and 24 hours postoperative after transferring to the ward.
For postoperative pain therapy, If the pain scale scores are ≥ 4, first will be IV ibuprofen 7.5 mg/kg immediately postoperative.
Regarding that maximum single dose of ibuprofen is 400mg , maximum daily dose is 40mg/kg .
Paracetamol will not be given within 6 hour of intraoperative administration. After 15 mins if the pain scale scores still ≥ 4, patients will receive pethidine 0.5 mg/kg I.V. as rescue analgesia, which may be repeated, taking in consideration that the total daily dose should not exceed 1.5 mg/kg(11), regarding that minimum period of pethidine rescue analgesic doses are from 2 to 4 hours and. The analgesic effect occurs after about 10 minutes following parenteral administration.
Antiemetics (IV 1.25 mg/kg dimenhydrinate or 0.15 mg/kg of metoclopramide or 0.1 mg/kg ondansetron) will be given in the case of postoperative nausea and vomiting .
The patient will be discharged when the pain is controlled as the pain scale < 3 and there is no nausea, vomiting, and/or bleeding. Post discharge, the FACES and VAS scales will be explained to the parents for further assessment of pain score post-operative day for 24 hrs.
The parents will be contacted by phone numbers to asses pain score and the dose of paracetamol \& ibuprofen will be documented.
Possible complications of local anesthetic toxicity will appear as hemodynamic instability in the form of hypotension and bradycardia and will be managed using bolus of crystalloids (20ml/kg),ephedrine (1-3mg) boluses and atropine (0.01mg/kg).
Any complications resulting from peripheral nerve blockade like: bleeding, infection or neuropathy, will be recorded and managed accordingly.
- Conditions
- Regional, Adenotonsillectomy
- Being tested
- ultrasound-guided glossopharyngeal nerve block (UGSGNB), ultrasound-guided maxillary nerve (UGMN), Placebo Block
- Keywords
- Ultrasound, Glossopharyngeal, Adenotonsillectomy, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided glossopharyngeal nerve block (UGSGNB)Procedure or 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 or 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 BlockProcedure or surgery
ultrasound-guided maxillary nerve (UGMN) and ultrasound-guided glossopharyngeal nerve block (UGSGNB) using normal saline as placebo effect
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Placebo Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
Time of the first claim for analgesia
Measured: 24 hours
Secondary outcomes (7)
Heart rate
Intraoperative monitoring of heart rate measured beats/minute
Measured: 2 hours
Intraoperative fentanyl consumption
Intraoperative fentanyl consumption in microgram
Measured: 2 hours
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
Measured: 24 hours
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.
Measured: 24 hours
Total pethidine requirements
Total pethidine requirements 24 hours postoperatively.
Measured: 24 hours
Post tonsillectomy bleeding.
Post tonsillectomy bleeding.
Measured: 24 hours
Blood Pressure
intraoperative monitoring of Systolic, diastolic and Mean Blood Pressure mmHg
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RegionalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagy Malak , MD, Cairo University
- Investigators
- Nagy malak, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379866
- Sponsor's protocol ID
- MS-389-2025
- Other IDs
- University
- Acronym
- Pediatrics
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Glossopharyngeal and Maxillary Nerve Blocks for Perioperative Pain Control in Adenotonsillectomy in Pediatrics: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07379866
- Acronym / sponsor ID
- Pediatrics / MS-389-2025
- Conditions
- Regional, Adenotonsillectomy
- Keywords
- Ultrasound, Glossopharyngeal, Adenotonsillectomy, Pediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be premedicated with oral midazolam 0.5 mg/kg prior to arriving in the operating room 30 min before the procedure.
Standard monitoring will be maintained throughout the procedure included electrocardiography, noninvasive arterial pressure, arterial oxygen saturation.
. If intravenous access is present, Fentanyl 1 μg/kg IV will be given and anesthesia will be induced using propofol 2-3 mg/kg and atracurium 0.5 mg/kg. If intravenous access is not present, anesthesia will be induced with inhalation of 8% sevoflurane in 100% oxygen under spontaneous ventilation and IV access will be established, fentanyl 1 µg/kg IV and atracurium 0.5 m g/kg IV will be given after achieving IV access. Endotracheal intubation will be done using an appropriate size endotracheal tube (ETT) and capnography attached. IV dexamethasone 150 μg/kg will be given. Anesthesia will be maintained using a 50:50 mixture of air and oxygen along with isoflurane 1.2% and the maintenance dose of atracurium 0.1 mg/kg each 20 minutes. Pressure-controlled ventilation and low fresh gas flows will be used. All patients will receive intraoperative analgesia in the form of single dose paracetamol 15 mg/kg.
Patients will be randomly allocated into two equal groups:
Block Group: 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.
Conventional Group: patients will receive multimodal analgesia for tonsillectomy operations in the form of single dose of IV paracetamol 15 mg/kg.
Tonsillectomies will be carried out by expert surgeon using the same electro-dissection surgical technique.
In block group:
Technique of ultrasound-guided glossopharyngeal nerve block (UGSGNB): posterior mandibular ramus approach 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 the 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. The same procedure will be then repeated on the contralateral side.
Technique of ultrasound-guided maxillary nerve (UGMNB): Suprazygomatic maxillary nerve blocks The curvilinear ultrasound probe will be placed in the infrazygomatic area, over the maxilla, angled 45° cephalad. This probe position allows visualization of the pterygopalatine fossa, limited anteriorly by the maxilla and posteriorly by the greater wing of the sphenoid. A 22- gauge, 5-cm nerve block needle will be inserted perpendicularly to the skin following aseptic preparation of the skin at the frontozygomatic angle formed by the posterior orbital rim and zygomatic . Once contact was made with the greater wing of the sphenoid, the needle will be redirected caudally and medially, and advances through the pterygomaxillary fissure into the pterygomaxillary fossa. The needle will be advanced using an out-of-plane approach, and the 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.
In both groups Baseline hemodynamics in the form of: non-invasive BP, HR, oxygen saturation will be recorded before induction of anesthesia. the intraoperative hemodynamics will be recorded at 15 minute intervals in addition to continuous monitoring of HR and oxygen saturation. If heart rate (HR) increases more than 20% of baseline an additional dose of fentanyl 1 µg/kg will be given , if blood pressure exceeding 20% from baseline an additional dose of fentanyl 1 µg/kg will be given with a maximum total dose of 5 mcg/kg if additional doses are required , if bradycardic atropine 0.01 mg/kg will be given. At the end of the surgery , Inhalational anesthesia will be discontinued and muscle relaxation will be reversed by atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) after the restoration of the patient's spontaneous breathing. The patient will be transferred to the post-anesthesia care unit (PACU) for 1 hours to complete recovery and monitoring and then will be sent to the ward. Quality of analgesia will be assessed using the Wong-Baker FACES scale for children more than 3 years of age up to 8 years of age and VAS score for older children every 30 minutes for 1 hours after recovery from anesthesia in PACU and every 2, 4, 8, 12, and 24 hours postoperative after transferring to the ward.
For postoperative pain therapy, If the pain scale scores are ≥ 4, first will be IV ibuprofen 7.5 mg/kg immediately postoperative.
Regarding that maximum single dose of ibuprofen is 400mg , maximum daily dose is 40mg/kg .
Paracetamol will not be given within 6 hour of intraoperative administration. After 15 mins if the pain scale scores still ≥ 4, patients will receive pethidine 0.5 mg/kg I.V. as rescue analgesia, which may be repeated, taking in consideration that the total daily dose should not exceed 1.5 mg/kg(11), regarding that minimum period of pethidine rescue analgesic doses are from 2 to 4 hours and. The analgesic effect occurs after about 10 minutes following parenteral administration.
Antiemetics (IV 1.25 mg/kg dimenhydrinate or 0.15 mg/kg of metoclopramide or 0.1 mg/kg ondansetron) will be given in the case of postoperative nausea and vomiting .
The patient will be discharged when the pain is controlled as the pain scale < 3 and there is no nausea, vomiting, and/or bleeding. Post discharge, the FACES and VAS scales will be explained to the parents for further assessment of pain score post-operative day for 24 hrs.
The parents will be contacted by phone numbers to asses pain score and the dose of paracetamol \& ibuprofen will be documented.
Possible complications of local anesthetic toxicity will appear as hemodynamic instability in the form of hypotension and bradycardia and will be managed using bolus of crystalloids (20ml/kg),ephedrine (1-3mg) boluses and atropine (0.01mg/kg).
Any complications resulting from peripheral nerve blockade like: bleeding, infection or neuropathy, will be recorded and managed accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Block Group | Active comparator | Procedure: ultrasound-guided glossopharyngeal nerve block (UGSGNB), Procedure: ultrasound-guided maxillary nerve (UGMN)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 |
| Conventional Group | Placebo comparator | Procedure: Placebo Blockpatients will receive multimodal analgesia for tonsillectomy operations in the form of single dose of IV paracetamol 15 mg/kg |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients aged 5 to 13 years
- American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy.
Key exclusion criteria (8 listed)
- Parents Refusal
- Cognitive impairment or developmental delays.
- Infection at injection site.
- Recent upper respiratory tract infection.
- Post-tonsillectomy bleeding, allergy to local anesthetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided glossopharyngeal nerve block (UGSGNB)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. | Procedure or surgery | Block Group |
| ultrasound-guided maxillary nerve (UGMN)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. | Procedure or surgery | Block Group |
| Placebo Blockultrasound-guided maxillary nerve (UGMN) and ultrasound-guided glossopharyngeal nerve block (UGSGNB) using normal saline as placebo effect | Procedure or surgery | Conventional Group |
Primary outcome
Time to first rescue analgesia
Time frame: 24 hours
Time of the first claim for analgesia
7 secondary outcomes
Heart rate
Time frame: 2 hours
Intraoperative fentanyl consumption
Time frame: 2 hours
Dietary intake
Time frame: 24 hours
Postoperative pain scores
Time frame: 24 hours
Total pethidine requirements
Time frame: 24 hours
Post tonsillectomy bleeding.
Time frame: 24 hours
Blood Pressure
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Regional
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nagy malak, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided glossopharyngeal nerve block (UGSGNB) and ultrasound-guided maxillary nerve (UGMN) in people with Regional and Adenotonsillectomy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nagy Malak, MD (+201552480258, nagymalak12345@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.