An interventional study of Bilateral Intraoral Glossopharyngeal Nerve Block in Postoperative Pain, Adenotonsillectomy and Pain, sponsored by Istanbul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Istanbul University · Not applicable, Interventional, and Treatment
This randomized controlled trial aims to evaluate the usefulness of the perfusion index (PI) as an objective measure of postoperative pain in children aged 1-12 years undergoing adenotonsillectomy. Participants will be randomized into two groups: a control group receiving standard general anesthesia and multimodal analgesia, and an intervention group receiving an additional bilateral glossopharyngeal nerve block with 0.25% bupivacaine. Postoperative PI measurements will be compared with validated pediatric pain scales, including the Face, Legs, Activity, Cry, Consolability (FLACC) and Wong-Baker FACES scales.
This single-center, prospective, randomized controlled study will include 50 pediatric patients aged 1-12 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective adenotonsillectomy. Participants will be randomized in a 1:1 ratio using sealed envelopes into a control group and a glossopharyngeal nerve block group.
All patients will receive A standardized anesthetic protocol will be applied to all participants. Inhalational induction of anesthesia will be initiated with sevoflurane using a fresh gas flow of 12 L/min and an inspired oxygen concentration of approximately 92%, with sevoflurane at 8%. After intravenous access is established, fentanyl 2 µg/kg and rocuronium 0.4 mg/kg will be administered to facilitate tracheal intubation.
The operating room temperature will be maintained between 20°C and 23°C throughout the procedure in order to minimize the potential influence of ambient temperature on peripheral perfusion. All patients will also receive active forced-air warming intraoperatively.
As part of the standardized perioperative management, all participants will receive ampicillin-sulbactam 25 mg/kg for surgical antimicrobial prophylaxis, dexamethasone 0.1 mg/kg, methylprednisolone 1 mg/kg, and paracetamol 15 mg/kg.
In the intervention group, a bilateral intraoral glossopharyngeal nerve block will be performed after induction of general anesthesia using 0.25% bupivacaine at a total dose of 0.2 mL/kg, divided equally between both sides, following negative aspiration and injection into the anterior or posterior tonsillar pillars.
Baseline PI measurements will be obtained preoperatively from the right index finger. Additional PI measurements will be obtained 20 minutes after tracheal intubation and during the postoperative recovery period. PI will also be assessed upon admission to and before discharge from the post-anesthesia care unit (PACU). At each measurement point, three consecutive readings will be recorded and their mean value will be used for statistical analysis.
Postoperative pain will be assessed using the FLACC scale in 1-3 years children and the Wong-Baker FACES Pain Rating Scale in 4-12 children. In both rating scales patients with a pain score of 6 or greater will receive intravenous ibuprofen at a dose of 10 mg/kg. Pain assessments will be performed during the postoperative recovery period, including after approximately 30 minutes of observation in the PACU. Vital signs, postoperative nausea and vomiting (PONV), rescue analgesic requirements, and other postoperative complications will also be recorded.
5,259 studies on the registry are indexed under Pain, Postoperative; 1,163 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 4,490 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Istanbul University is the lead sponsor of 509 studies on the registry; 77 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
standard general anesthesia and multimodal analgesia, no nerve block
Participants in this group will receive standardized general anesthesia and multimodal perioperative analgesia in addition to a bilateral intraoral glossopharyngeal nerve block with 0.25% bupivacaine.
Procedure: Bilateral Intraoral Glossopharyngeal Nerve Block
After induction of general anesthesia, a bilateral intraoral glossopharyngeal nerve block will be performed using 0.25% bupivacaine at a total volume of 0.2 mL/kg, divided equally between both sides. Following negative aspiration, the local anesthetic will be injected into the anterior or posterior tonsillar pillars bilaterally.
Correlation Between Perfusion Index and FLACC Pain Score
The correlation between postoperative perfusion index and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale score will be evaluated in children aged 1-3 years. The FLACC Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the FLACC Scale score.
Time frame: During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit.
Correlation Between Perfusion Index and Wong-Baker FACES Pain Score
The correlation between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score will be evaluated in children older than 3 years. The Wong-Baker FACES Pain Rating Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score.
Time frame: During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit.
Change in Perfusion Index During the Perioperative Period
Perfusion index values will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, upon admission to the PACU, and before discharge from the PACU. Three consecutive measurements will be obtained at each time point and the mean value will be used for analysis. Changes in PI over time and differences between the study groups will be evaluated.
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Postoperative Pain Score
Postoperative pain severity will be assessed using age-appropriate validated pediatric pain scales. The FLACC scale will be used in children aged 1-3 years, and the Wong-Baker FACES Pain Rating Scale will be used in children older than 3 years. Both scales range from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: Approximately 30 minutes after admission to the PACU
Requirement for Rescue Analgesia
The number and proportion of participants requiring rescue analgesia during postoperative recovery will be recorded. Intravenous ibuprofen 10 mg/kg will be administered according to the predefined postoperative pain criteria.
Time frame: During the PACU stay on the day of surgery
Incidence of Postoperative Nausea and Vomiting
The incidence of postoperative nausea and/or vomiting will be recorded during postoperative recovery.
Time frame: During the PACU stay on the day of surgery
Perioperative Heart Rate
Heart rate, measured in beats per minute, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Perioperative Systolic Blood Pressure
Systolic blood pressure, measured in mmHg, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Perioperative Diastolic Blood Pressure
Diastolic blood pressure , measured in mmHg, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Peripheral Oxygen Saturation
Peripheral oxygen saturation, expressed as a percentage, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Plan to share: No
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Started Oct 2026 (actual). Primary completion is estimated for Nov 2026, 1 month after the start.
Of 1,914 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 1 month is below that.
Counting every sponsor, half of 1,927 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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