Pain, PostoperativeNCT07873307
Glossopharyngeal Nerve Block in Pediatric Adenotonsillectomy Operations
A study testing Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection and Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection in people with Pain, Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Tonsilloadenoidectomy operations in pediatric patients cause local pain. Especially, in order to reduce the need for narcotic painkillers, to ensure patient compliance and well-being, and to provide better quality pain management regional pain prevention methods, which are included in the guidelines, are applied to… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection and Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients scheduled for adenotonsillectomy operations
- Patients with American Society of Anesthesiology (ASA) Class 1-2
- Patients with parental consent
Who cannot join
- Patients with diabetes mellitus
- Patients with heart, kidney, liver diseases
- Patients with hypersensitivity to the drugs to be used
- Patients with peritonsillar abscess
- Patients with swallowing disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anesthesiology
Istanbul, Fatih, 34093
About this study
Official title: The Effect of Glossopharyngeal Nerve Block on Postoperative Analgesia and Stomach Volume in Pediatric Adenotonsillectomy Operations
Tonsilloadenoidectomy operations in pediatric patients cause local pain. Especially, in order to reduce the need for narcotic painkillers, to ensure patient compliance and well-being, and to provide better quality pain management regional pain prevention methods, which are included in the guidelines, are applied to these patients. One of these methods is glossopharyngeal nerve block. This block is the blocks that the investigators routinely apply to patients in different uses for the purpose of pain management before/after adenotonsillectomy operations in the clinic. The investigators plan to apply the glossopharyngeal nerve card that the investigators will make in different doses and follow the patient's pain and stomach volume after the surgery.
Read the detailed description
In this study, a group of patients who will undergo adenotonsillectomy surgery will be performed glossopharyngeal nerve block with 0,2 milliliter/kilogram (ml/kg) %0.125 bupivacaine bilaterally; the other group will be performed glossopharyngeal nerve block with 0,2 milliliter/kilogram %0.25 bupivacaine bilaterally. Postoperatively, patient's pain level, stomach volume, possible undesirable results, hospital stay, and satisfaction level will be monitored and recorded. The results will be compared. After reading and signing the informed consent form, the block will be applied under general anesthesia in the operating room with monitorization, and then the operation will be performed under general anesthesia. Post-operative follow-up will be done.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection, Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection
- Keywords
- Glossopharyngeal nerve block, Adenotonsillectomy operations, Regional Anesthesia, Analgesic consumption, Postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injectionDrug
Also called marcaine
In this group, glossopharyngeal nerve block will be performed with 0,2 milliliter/kilogram (ml/kg) +0,2 milliliter/kilogram (ml/kg) %0.125 bupivacaine for each block site
Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injectionDrug
Also called Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 ml/kg+ 0,2 ml/kg injection
In this group, glossopharyngeal nerve block will be performed with 0,2 milliliter/kilogram (ml/kg) +0,2 milliliter/kilogram (ml/kg) %0.25 bupivacaine for each block site
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | In this group, glossopharyngeal block will be performed with 0.2 milliliter/kilogram (ml/kg) of %0.125 bupivacaine bilaterally Receives: Drug: Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection |
| Group 2 | Active comparator | In this group, glossopharyngeal block will be performed with 0.2 milliliter/kilogram (ml/kg) of %0.25 bupivacaine bilaterally Receives: Drug: Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Measured: 240 Minutes Postoperatively
Secondary outcomes (5)
The gag reflex
The gag reflex is assessed in the recovery room using a 4-point scale ranging from 0 to 3, with 0 indicating no gag reflex and 3 indicating a severe gag reflex reaction. Higher scores indicate a more pronounced gag reflex response.
Measured: 30 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Measured: 30 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Measured: 60 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Measured: 120 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Measured: 240 Minutes Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start15 Dec 2022
- Primary completion15 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Altun, Istanbul University
- Investigators
- Kübra Ozkan, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873307
- Sponsor's protocol ID
- 2022/1854
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmed SA, Omara AF. The Effect of Glossopharyngeal Nerve Block on Post-Tonsillectomy Pain of Children; Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 30;9(2):e90854. doi: 10.5812/aapm.90854. eCollection 2019 Apr.
PubMed 31341828Rao S, Rao S. Glossopharyngeal Nerve Block: The Premolar Approach. Craniomaxillofac Trauma Reconstr. 2018 Dec;11(4):331-332. doi: 10.1055/s-0037-1606249. Epub 2017 Aug 25.
PubMed 30574279
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glossopharyngeal Nerve Block on Postoperative Analgesia and Stomach Volume in Pediatric Adenotonsillectomy Operations
- ClinicalTrials.gov ID
- NCT07873307
- Acronym / sponsor ID
- 2022/1854
- Conditions
- Pain, Postoperative
- Keywords
- Glossopharyngeal nerve block, Adenotonsillectomy operations, Regional Anesthesia, Analgesic consumption, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 14 Oct 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.
Tonsilloadenoidectomy operations in pediatric patients cause local pain. Especially, in order to reduce the need for narcotic painkillers, to ensure patient compliance and well-being, and to provide better quality pain management regional pain prevention methods, which are included in the guidelines, are applied to these patients. One of these methods is glossopharyngeal nerve block. This block is the blocks that the investigators routinely apply to patients in different uses for the purpose of pain management before/after adenotonsillectomy operations in the clinic. The investigators plan to apply the glossopharyngeal nerve card that the investigators will make in different doses and follow the patient's pain and stomach volume after the surgery.
Detailed description
In this study, a group of patients who will undergo adenotonsillectomy surgery will be performed glossopharyngeal nerve block with 0,2 milliliter/kilogram (ml/kg) %0.125 bupivacaine bilaterally; the other group will be performed glossopharyngeal nerve block with 0,2 milliliter/kilogram %0.25 bupivacaine bilaterally. Postoperatively, patient's pain level, stomach volume, possible undesirable results, hospital stay, and satisfaction level will be monitored and recorded. The results will be compared. After reading and signing the informed consent form, the block will be applied under general anesthesia in the operating room with monitorization, and then the operation will be performed under general anesthesia. Post-operative follow-up will be done.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injectionIn this group, glossopharyngeal block will be performed with 0.2 milliliter/kilogram (ml/kg) of %0.125 bupivacaine bilaterally |
| Group 2 | Active comparator | Drug: Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injectionIn this group, glossopharyngeal block will be performed with 0.2 milliliter/kilogram (ml/kg) of %0.25 bupivacaine bilaterally |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients scheduled for adenotonsillectomy operations
- Patients with American Society of Anesthesiology (ASA) Class 1-2
- Patients with parental consent
Key exclusion criteria (5 listed)
- Patients with diabetes mellitus
- Patients with heart, kidney, liver diseases
- Patients with hypersensitivity to the drugs to be used
- Patients with peritonsillar abscess
- Patients with swallowing disorder
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 |
|---|---|---|
| Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injectionAlso: marcaineIn this group, glossopharyngeal nerve block will be performed with 0,2 milliliter/kilogram (ml/kg) +0,2 milliliter/kilogram (ml/kg) %0.125 bupivacaine for each block site | Drug | Group 1 |
| Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injectionAlso: Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 ml/kg+ 0,2 ml/kg injectionIn this group, glossopharyngeal nerve block will be performed with 0,2 milliliter/kilogram (ml/kg) +0,2 milliliter/kilogram (ml/kg) %0.25 bupivacaine for each block site | Drug | Group 2 |
Primary outcome
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 30 Minutes Postoperatively
Time frame: 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 30 Minutes Postoperatively
Time frame: 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 60 Minutes Postoperatively
Time frame: 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 60 Minutes Postoperatively
Time frame: 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 120 Minutes Postoperatively
Time frame: 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 120 Minutes Postoperatively
Time frame: 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 240 Minutes Postoperatively
Time frame: 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 240 Minutes Postoperatively
Time frame: 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
5 secondary outcomes
The gag reflex
Time frame: 30 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Time frame: 30 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Time frame: 60 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Time frame: 120 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Time frame: 240 Minutes Postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 31341828Ahmed SA, Omara AF. The Effect of Glossopharyngeal Nerve Block on Post-Tonsillectomy Pain of Children; Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 30;9(2):e90854. doi: 10.5812/aapm.90854. eCollection 2019 Apr.
- Background: PubMed 30574279Rao S, Rao S. Glossopharyngeal Nerve Block: The Premolar Approach. Craniomaxillofac Trauma Reconstr. 2018 Dec;11(4):331-332. doi: 10.1055/s-0037-1606249. Epub 2017 Aug 25.
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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. This study is not recruiting at the moment.
Kübra Ozkan, MD principal investigator
Istanbul 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 Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection and Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection in people with Pain, Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Oct 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 30 Minutes Postoperatively (time frame: 30 Minutes Postoperatively). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07873307, which also lists 2 linked publications.
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 14 Oct 2026.