Post Tonsillectomy PainTONwoPANCT07370129
Transnasal Sphenopalatine Ganglion Block for Postoperative Pain and Recovery in Tonsillectomy (TONwoPA)
A study testing Transnasal Transmucosal Sphenopalatine Ganglion Block, Lidocaine %5 and Saline (0.9% NaCl) in people with Post Tonsillectomy Pain and Post Operative Analgesia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to evaluate the effectiveness of transnasal transmucosal sphenopalatine ganglion block in reducing post-tonsillectomy pain. The study also investigates its impact on rescue analgesic requirements and postoperative recovery by comparing 5% lidocaine with placebo. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Post Tonsillectomy Pain, Post Operative Analgesia, Opioid Consumption
- What is being tested?
- Transnasal Transmucosal Sphenopalatine Ganglion Block, Lidocaine %5 and Saline (0.9% NaCl)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 30 Aug 2026
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥ 12 years
- Patients weighing ≥ 50 kg
- Patients without coagulation disorders
- ASA physical status I-II patients scheduled for tonsillectomy
- Patients who are fully oriented and able to cooperate
Who cannot join
- Lack of informed consent
- Patients aged < 12 years
- Patients weighing < 50 kg
- Body mass index (BMI) > 30 kg/m²
- History of allergy to local anesthetics
- History of facial trauma or infection
Show all 11Show fewer
- Presence of coagulation disorders
- Patients who are disoriented and/or unable to cooperate
- Patients with comorbidities requiring opioid use
- History of neuropathic pain
- Patients with chronic pain syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Transnasal Sphenopalatine Ganglion Block on Pain Relief and Recovery Following Tonsillectomy
The aim of this clinical trial is to evaluate the effectiveness of transnasal transmucosal sphenopalatine ganglion block in reducing post-tonsillectomy pain. The study also investigates its impact on rescue analgesic requirements and postoperative recovery by comparing 5% lidocaine with placebo.
Participants will receive a transnasal transmucosal sphenopalatine ganglion block with either 5% lidocaine or placebo (saline). Postoperative pain levels and opioid consumption will be monitored during the first 24 hours after surgery. In addition, length of hospital stay, the occurrence of primary and secondary post-tonsillectomy hemorrhage up to 14 days, unplanned hospital readmissions after discharge, and patient satisfaction on postoperative day 14 will be assessed.
Read the detailed description
The primary objective of this study is to compare the effects of preemptive transnasal transmucosal sphenopalatine ganglion block performed with either 0.9% saline (placebo) or 5% lidocaine (active drug), in addition to standard multimodal analgesia, on postoperative pain and recovery in patients aged 12 years and older undergoing tonsillectomy.
All patients will undergo routine monitoring, including noninvasive blood pressure, electrocardiography (ECG), peripheral oxygen saturation (SpO₂), body temperature, end-tidal carbon dioxide (ETCO₂), and bispectral index (BIS), followed by induction of general anesthesia.
For induction of general anesthesia, intravenous lidocaine 1 mg/kg, fentanyl 1 µg/kg, and propofol 1-3 mg/kg (adjusted according to depth of anesthesia monitoring) will be administered. Neuromuscular blockade required for endotracheal intubation and surgery will be achieved with intravenous rocuronium 0.8 mg/kg. Airway security will be ensured by orotracheal intubation. Anesthesia maintenance will be provided as total intravenous anesthesia (TIVA) using a propofol and remifentanil combination, guided by BIS monitoring.
Immediately after induction of anesthesia, patients will be randomized into either the Saline Group (placebo) or the Lidocaine Group (5% lidocaine, active drug) using a computer-generated randomization program.
Before the start of surgery, a preemptive transnasal transmucosal sphenopalatine ganglion block will be performed. Patients in the placebo group will receive 0.9% isotonic saline, while patients in the lidocaine group will receive 5% lidocaine. Cotton-tipped applicators will be used for the block procedure, with one applicator inserted into each nostril. The applicators will be advanced parallel to the nasal floor from the middle turbinate until resistance is encountered. Contact of the applicator with the posterior wall of the nasopharynx will ensure transmucosal proximity to the sphenopalatine ganglion. The assigned solutions will be applied via the applicators according to group allocation, aiming for transmucosal absorption and therapeutic effect on the target ganglion.
The applicators will be shortened as necessary to avoid interference with the surgical field and will be left in place throughout the surgery. Before emergence from anesthesia, the same solution will be reapplied through the applicators. Patients will be awakened approximately 10 minutes after the second application, prior to extubation. The total volume of solution administered per patient will be 3 mL: 2 mL (1 mL per applicator) before surgery and 1 mL (0.5 mL per applicator) after surgery.
As part of standard multimodal analgesia, all patients will receive intravenous paracetamol 1 g, ibuprofen 400 mg, and dexamethasone 8 mg. For postoperative nausea and vomiting prophylaxis, ondansetron 4 mg IV will be administered before the end of surgery. Extubation will be performed after neuromuscular recovery is confirmed with a train-of-four (TOF) ratio ≥ 0.9, using sugammadex as needed.
Following transfer to the post-anesthesia care unit (PACU), all patients will receive intravenous fentanyl via patient-controlled analgesia (PCA) and will continue to be monitored using standardized case report forms. Fentanyl PCA will be prepared for all patients with a concentration of 10 µg/mL, a bolus dose of 0.2 µg/kg, a lockout interval of 12 minutes, and a maximum dose of 5 µg/kg over a 4-hour period.
In the preoperative period, demographic data of all patients will be recorded along with American Society of Anesthesiologists (ASA) physical status, Mallampati score, and Brodsky Tonsil Hypertrophy Scale. The presence of preoperative dysphagia, aspiration risk, and throat pain will also be documented.
During the intraoperative period, whether endotracheal intubation is achieved on the first attempt and the occurrence of any complications during intubation or extubation (including the type of complication, if present) will be recorded. In addition, heart rate (HR), arterial blood pressure values (systolic, diastolic, and mean arterial pressure [MAP]), peripheral oxygen saturation (SpO₂), end-tidal carbon dioxide (ETCO₂), and bispectral index (BIS) values will be recorded before anesthesia induction, after induction (corresponding to the pre-block period), and every 5 minutes intraoperatively.
Postoperative follow-up will be performed in the post-anesthesia care unit (PACU), at postoperative hours 1, 2, 4, 8, 16, and 24, and on postoperative day 14. In the PACU, patients will be evaluated by an anesthesiologist for pain (assessed using the Numeric Rating Scale [NRS]), postoperative nausea and vomiting, and potential airway-related complications, including aspiration, hoarseness, laryngospasm, dyspnea, stridor, and oxygen requirement. Patients with a Modified Aldrete Score ≥ 9 will be discharged from the PACU.
At postoperative hours 1, 2, 4, 8, 16, and 24, NRS pain scores will be recorded. In addition, the presence of nausea and vomiting, the need for additional (rescue) analgesia, and any airway-related complications will be documented. The time to first oral intake of fluids and solid foods, as well as any associated pain during oral intake, will also be monitored.
Finally, length of hospital stay, the occurrence of primary and secondary post-tonsillectomy hemorrhage up to postoperative day 14, any unplanned hospital readmissions after discharge, and patient satisfaction on postoperative day 14 will be assessed.
- Conditions
- Post Tonsillectomy Pain, Post Operative Analgesia, Opioid Consumption, Sphenopalatine Ganglion Block, Tonsillar Surgery Complications
- Being tested
- Transnasal Transmucosal Sphenopalatine Ganglion Block, Lidocaine %5, Saline (0.9% NaCl)
- Keywords
- Transmucosal Sphenopalatine Ganglion Block, Sphenopalatine Ganglion Block, Tonsillectomy Without Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal Transmucosal Sphenopalatine Ganglion BlockProcedure or surgery
Before the start of surgery, a preemptive transnasal transmucosal sphenopalatine ganglion block will be performed using cotton-tipped applicators. The assigned solutions will be administered via the applicators according to group allocation.
Lidocaine %5Procedure or surgery
Transnasal Transmucosal Sphenopalatine Ganglion Block with Lidocaine %5
Saline (0.9% NaCl)Procedure or surgery
Transnasal Transmucosal Sphenopalatine Ganglion Block with Saline (0.9% NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Group Lidocaine | Experimental | Transnasal sphenopalatine ganglion block will be performed using cotton-tipped applicators soaked with 5% lidocaine hydrochloride, which will be prepared by diluting 10% lidocaine hydrochloride with 0.9% sodium chloride (normal saline). Receives: Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block; Procedure: Lidocaine %5 |
| Group Saline | Placebo comparator | In the comparison group, a transnasal sphenopalatine ganglion block will be performed as a placebo using cotton-tipped applicators soaked with 0.9% sodium chloride (normal saline). Receives: Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block; Procedure: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative NRS Score and Opioid Consumption
The NRS (Numeric Rating Scale) score will be used to assess the pain during follow ups. Scale: 0 (no pain) to 10 (worst pain). Higher scores on the NRS indicate worse pain.
Measured: Postoperative 1. 2. 4. 8. 16. and 24. Hours
Secondary outcomes (2)
Parameters for Postoperative Complications and Recovery Process
Length of hospital stay, the occurrence of primary and secondary post-tonsillectomy hemorrhage up to postoperative day 14, the presence of any complaints requiring unplanned hospital readmission after discharge, and patient satisfaction on postoperative day 14 will be assessed.
Measured: Postoperative 14th Day
Feeding Tolerance and Time to First Tolerated Oral Intake
The timing of the patient's first oral intake of liquids and solids, and any accompanying pain, will also be monitored.
Measured: Postoperative 1.2.4.8.16. and 24. Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start30 Aug 2025
- Primary completion15 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Post Tonsillectomy PainStudies of the same condition, open and under way.
- More trials run by Ankara 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
- A randomized, placebo-controlled interventional clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıddık Aytuğ, Ankara University
- Investigators
- İbrahim Aşık, Professor, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370129
- Sponsor's protocol ID
- 2025000458
- Other IDs
- 25-AKD-116
- Acronym
- TONwoPA
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study was not designed with a data-sharing plan and to ensure participant confidentiality.
Publications
Nelson Textbook of Pediatrics Twenty Second Edition Pediatric Pain Management Nelson Textbook of Pediatrics, Chapter 93, 677-700.e2
Rajan S, Sasikumar NK, Rudrahitlu V, Mathew J, Barua K, Kumar L. Effects of bilateral transmucosal sphenopalatine ganglion block on intraoperative anesthetic requirements and recovery profile in children undergoing palatoplasty under general anesthesia. J Anaesthesiol Clin Pharmacol. 2023 Apr-Jun;39(2):220-225. doi: 10.4103/joacp.joacp_279_21. Epub 2023 Feb 3.
PubMed 37564832Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.
PubMed 32303377Bucard BM, Assad AR, Vercosa N, Cavalcanti IL. Sphenopalatine ganglion block for postoperative analgesia after transsphenoidal hypophysectomy: A pilot study. Eur J Anaesthesiol. 2025 Apr 1;42(4):368-370. doi: 10.1097/EJA.0000000000002112. Epub 2025 Jan 9. No abstract available.
PubMed 39789934Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.
PubMed 30719401Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
PubMed 21956040Robbins MS, Robertson CE, Kaplan E, Ailani J, Charleston L 4th, Kuruvilla D, Blumenfeld A, Berliner R, Rosen NL, Duarte R, Vidwan J, Halker RB, Gill N, Ashkenazi A. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. Headache. 2016 Feb;56(2):240-58. doi: 10.1111/head.12729. Epub 2015 Nov 30.
PubMed 26615983Smith L, Balakrishnan K, Pan S, Tsui BCH. Suprazygomatic maxillary (SZM) nerve blocks for perioperative pain control in pediatric tonsillectomy and adenoidectomy. J Clin Anesth. 2021 Aug;71:110240. doi: 10.1016/j.jclinane.2021.110240. Epub 2021 Mar 20. No abstract available.
PubMed 33756446Mahrose R, Shorbagy MS, Kasem AA. Opioid Free Ptyregopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations: A Randomized Controlled Trial. Anesth Pain Med. 2024 Jul 10;14(3):e146617. doi: 10.5812/aapm-146617. eCollection 2024 Jun.
PubMed 39416797Vlok R, Melhuish TM, Chong C, Ryan T, White LD. Adjuncts to local anaesthetics in tonsillectomy: a systematic review and meta-analysis. J Anesth. 2017 Aug;31(4):608-616. doi: 10.1007/s00540-017-2310-x. Epub 2017 Jan 24.
PubMed 28120104Ahmed 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 31341828Park HP, Hwang JW, Park SH, Jeon YT, Bahk JH, Oh YS. The effects of glossopharyngeal nerve block on postoperative pain relief after tonsillectomy: the importance of the extent of obtunded gag reflex as a clinical indicator. Anesth Analg. 2007 Jul;105(1):267-71. doi: 10.1213/01.ane.0000266440.62424.f1.
PubMed 17578986Mohamed SK, Ibraheem AS, Abdelraheem MG. Preoperative intravenous dexamethasone combined with glossopharyngeal nerve block: role in pediatric postoperative analgesia following tonsillectomy. Eur Arch Otorhinolaryngol. 2009 Nov;266(11):1815-9. doi: 10.1007/s00405-009-0937-4. Epub 2009 Mar 5.
PubMed 19263066Fedorowicz Z, van Zuuren EJ, Nasser M, Carter B, Al Langawi JH. Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy. Cochrane Database Syst Rev. 2013 Sep 10;2013(9):CD007806. doi: 10.1002/14651858.CD007806.pub4.
PubMed 24022333Bean-Lijewski JD. Glossopharyngeal nerve block for pain relief after pediatric tonsillectomy: retrospective analysis and two cases of life-threatening upper airway obstruction from an interrupted trial. Anesth Analg. 1997 Jun;84(6):1232-8. doi: 10.1097/00000539-199706000-00011.
PubMed 9174298
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transnasal Sphenopalatine Ganglion Block on Pain Relief and Recovery Following Tonsillectomy
- ClinicalTrials.gov ID
- NCT07370129
- Acronym / sponsor ID
- TONwoPA / 2025000458
- Conditions
- Post Tonsillectomy Pain, Post Operative Analgesia, Opioid Consumption, Sphenopalatine Ganglion Block, Tonsillar Surgery Complications
- Keywords
- Transmucosal Sphenopalatine Ganglion Block, Sphenopalatine Ganglion Block, Tonsillectomy Without Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 27 Jan 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.
The aim of this clinical trial is to evaluate the effectiveness of transnasal transmucosal sphenopalatine ganglion block in reducing post-tonsillectomy pain. The study also investigates its impact on rescue analgesic requirements and postoperative recovery by comparing 5% lidocaine with placebo.
Participants will receive a transnasal transmucosal sphenopalatine ganglion block with either 5% lidocaine or placebo (saline). Postoperative pain levels and opioid consumption will be monitored during the first 24 hours after surgery. In addition, length of hospital stay, the occurrence of primary and secondary post-tonsillectomy hemorrhage up to 14 days, unplanned hospital readmissions after discharge, and patient satisfaction on postoperative day 14 will be assessed.
Detailed description
The primary objective of this study is to compare the effects of preemptive transnasal transmucosal sphenopalatine ganglion block performed with either 0.9% saline (placebo) or 5% lidocaine (active drug), in addition to standard multimodal analgesia, on postoperative pain and recovery in patients aged 12 years and older undergoing tonsillectomy.
All patients will undergo routine monitoring, including noninvasive blood pressure, electrocardiography (ECG), peripheral oxygen saturation (SpO₂), body temperature, end-tidal carbon dioxide (ETCO₂), and bispectral index (BIS), followed by induction of general anesthesia.
For induction of general anesthesia, intravenous lidocaine 1 mg/kg, fentanyl 1 µg/kg, and propofol 1-3 mg/kg (adjusted according to depth of anesthesia monitoring) will be administered. Neuromuscular blockade required for endotracheal intubation and surgery will be achieved with intravenous rocuronium 0.8 mg/kg. Airway security will be ensured by orotracheal intubation. Anesthesia maintenance will be provided as total intravenous anesthesia (TIVA) using a propofol and remifentanil combination, guided by BIS monitoring.
Immediately after induction of anesthesia, patients will be randomized into either the Saline Group (placebo) or the Lidocaine Group (5% lidocaine, active drug) using a computer-generated randomization program.
Before the start of surgery, a preemptive transnasal transmucosal sphenopalatine ganglion block will be performed. Patients in the placebo group will receive 0.9% isotonic saline, while patients in the lidocaine group will receive 5% lidocaine. Cotton-tipped applicators will be used for the block procedure, with one applicator inserted into each nostril. The applicators will be advanced parallel to the nasal floor from the middle turbinate until resistance is encountered. Contact of the applicator with the posterior wall of the nasopharynx will ensure transmucosal proximity to the sphenopalatine ganglion. The assigned solutions will be applied via the applicators according to group allocation, aiming for transmucosal absorption and therapeutic effect on the target ganglion.
The applicators will be shortened as necessary to avoid interference with the surgical field and will be left in place throughout the surgery. Before emergence from anesthesia, the same solution will be reapplied through the applicators. Patients will be awakened approximately 10 minutes after the second application, prior to extubation. The total volume of solution administered per patient will be 3 mL: 2 mL (1 mL per applicator) before surgery and 1 mL (0.5 mL per applicator) after surgery.
As part of standard multimodal analgesia, all patients will receive intravenous paracetamol 1 g, ibuprofen 400 mg, and dexamethasone 8 mg. For postoperative nausea and vomiting prophylaxis, ondansetron 4 mg IV will be administered before the end of surgery. Extubation will be performed after neuromuscular recovery is confirmed with a train-of-four (TOF) ratio ≥ 0.9, using sugammadex as needed.
Following transfer to the post-anesthesia care unit (PACU), all patients will receive intravenous fentanyl via patient-controlled analgesia (PCA) and will continue to be monitored using standardized case report forms. Fentanyl PCA will be prepared for all patients with a concentration of 10 µg/mL, a bolus dose of 0.2 µg/kg, a lockout interval of 12 minutes, and a maximum dose of 5 µg/kg over a 4-hour period.
In the preoperative period, demographic data of all patients will be recorded along with American Society of Anesthesiologists (ASA) physical status, Mallampati score, and Brodsky Tonsil Hypertrophy Scale. The presence of preoperative dysphagia, aspiration risk, and throat pain will also be documented.
During the intraoperative period, whether endotracheal intubation is achieved on the first attempt and the occurrence of any complications during intubation or extubation (including the type of complication, if present) will be recorded. In addition, heart rate (HR), arterial blood pressure values (systolic, diastolic, and mean arterial pressure [MAP]), peripheral oxygen saturation (SpO₂), end-tidal carbon dioxide (ETCO₂), and bispectral index (BIS) values will be recorded before anesthesia induction, after induction (corresponding to the pre-block period), and every 5 minutes intraoperatively.
Postoperative follow-up will be performed in the post-anesthesia care unit (PACU), at postoperative hours 1, 2, 4, 8, 16, and 24, and on postoperative day 14. In the PACU, patients will be evaluated by an anesthesiologist for pain (assessed using the Numeric Rating Scale [NRS]), postoperative nausea and vomiting, and potential airway-related complications, including aspiration, hoarseness, laryngospasm, dyspnea, stridor, and oxygen requirement. Patients with a Modified Aldrete Score ≥ 9 will be discharged from the PACU.
At postoperative hours 1, 2, 4, 8, 16, and 24, NRS pain scores will be recorded. In addition, the presence of nausea and vomiting, the need for additional (rescue) analgesia, and any airway-related complications will be documented. The time to first oral intake of fluids and solid foods, as well as any associated pain during oral intake, will also be monitored.
Finally, length of hospital stay, the occurrence of primary and secondary post-tonsillectomy hemorrhage up to postoperative day 14, any unplanned hospital readmissions after discharge, and patient satisfaction on postoperative day 14 will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, placebo-controlled interventional clinical study
| Arm | Type | Receives |
|---|---|---|
| Group Lidocaine | Experimental | Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block, Procedure: Lidocaine %5Transnasal sphenopalatine ganglion block will be performed using cotton-tipped applicators soaked with 5% lidocaine hydrochloride, which will be prepared by diluting 10% lidocaine hydrochloride with 0.9% sodium chloride (normal saline). |
| Group Saline | Placebo comparator | Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block, Procedure: Saline (0.9% NaCl)In the comparison group, a transnasal sphenopalatine ganglion block will be performed as a placebo using cotton-tipped applicators soaked with 0.9% sodium chloride (normal saline). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 12 years
- Patients weighing ≥ 50 kg
- Patients without coagulation disorders
- ASA physical status I-II patients scheduled for tonsillectomy
- Patients who are fully oriented and able to cooperate
Key exclusion criteria (11 listed)
- Lack of informed consent
- Patients aged < 12 years
- Patients weighing < 50 kg
- Body mass index (BMI) > 30 kg/m²
- History of 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 |
|---|---|---|
| Transnasal Transmucosal Sphenopalatine Ganglion BlockBefore the start of surgery, a preemptive transnasal transmucosal sphenopalatine ganglion block will be performed using cotton-tipped applicators. The assigned solutions will be administered via the applicators according to group allocation. | Procedure or surgery | Group Lidocaine, Group Saline |
| Lidocaine %5Transnasal Transmucosal Sphenopalatine Ganglion Block with Lidocaine %5 | Procedure or surgery | Group Lidocaine |
| Saline (0.9% NaCl)Transnasal Transmucosal Sphenopalatine Ganglion Block with Saline (0.9% NaCl) | Procedure or surgery | Group Saline |
Primary outcome
Postoperative NRS Score and Opioid Consumption
Time frame: Postoperative 1. 2. 4. 8. 16. and 24. Hours
The NRS (Numeric Rating Scale) score will be used to assess the pain during follow ups. Scale: 0 (no pain) to 10 (worst pain). Higher scores on the NRS indicate worse pain.
2 secondary outcomes
Parameters for Postoperative Complications and Recovery Process
Time frame: Postoperative 14th Day
Feeding Tolerance and Time to First Tolerated Oral Intake
Time frame: Postoperative 1.2.4.8.16. and 24. Hours
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 13 Oct 2026.
- BackgroundNelson Textbook of Pediatrics Twenty Second Edition Pediatric Pain Management Nelson Textbook of Pediatrics, Chapter 93, 677-700.e2
- Background: PubMed 37564832Rajan S, Sasikumar NK, Rudrahitlu V, Mathew J, Barua K, Kumar L. Effects of bilateral transmucosal sphenopalatine ganglion block on intraoperative anesthetic requirements and recovery profile in children undergoing palatoplasty under general anesthesia. J Anaesthesiol Clin Pharmacol. 2023 Apr-Jun;39(2):220-225. doi: 10.4103/joacp.joacp_279_21. Epub 2023 Feb 3.
- Background: PubMed 32303377Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.
- Background: PubMed 39789934Bucard BM, Assad AR, Vercosa N, Cavalcanti IL. Sphenopalatine ganglion block for postoperative analgesia after transsphenoidal hypophysectomy: A pilot study. Eur J Anaesthesiol. 2025 Apr 1;42(4):368-370. doi: 10.1097/EJA.0000000000002112. Epub 2025 Jan 9. No abstract available.
- Background: PubMed 30719401Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.
- Background: PubMed 21956040Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
- Background: PubMed 26615983Robbins MS, Robertson CE, Kaplan E, Ailani J, Charleston L 4th, Kuruvilla D, Blumenfeld A, Berliner R, Rosen NL, Duarte R, Vidwan J, Halker RB, Gill N, Ashkenazi A. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. Headache. 2016 Feb;56(2):240-58. doi: 10.1111/head.12729. Epub 2015 Nov 30.
- Background: PubMed 33756446Smith L, Balakrishnan K, Pan S, Tsui BCH. Suprazygomatic maxillary (SZM) nerve blocks for perioperative pain control in pediatric tonsillectomy and adenoidectomy. J Clin Anesth. 2021 Aug;71:110240. doi: 10.1016/j.jclinane.2021.110240. Epub 2021 Mar 20. No abstract available.
- Background: PubMed 39416797Mahrose R, Shorbagy MS, Kasem AA. Opioid Free Ptyregopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations: A Randomized Controlled Trial. Anesth Pain Med. 2024 Jul 10;14(3):e146617. doi: 10.5812/aapm-146617. eCollection 2024 Jun.
- Background: PubMed 28120104Vlok R, Melhuish TM, Chong C, Ryan T, White LD. Adjuncts to local anaesthetics in tonsillectomy: a systematic review and meta-analysis. J Anesth. 2017 Aug;31(4):608-616. doi: 10.1007/s00540-017-2310-x. Epub 2017 Jan 24.
- 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 17578986Park HP, Hwang JW, Park SH, Jeon YT, Bahk JH, Oh YS. The effects of glossopharyngeal nerve block on postoperative pain relief after tonsillectomy: the importance of the extent of obtunded gag reflex as a clinical indicator. Anesth Analg. 2007 Jul;105(1):267-71. doi: 10.1213/01.ane.0000266440.62424.f1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study was not designed with a data-sharing plan and to ensure participant confidentiality.
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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.
İbrahim Aşık, Professor study chair
Ankara 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 Transnasal Transmucosal Sphenopalatine Ganglion Block, Lidocaine %5 and Saline (0.9% NaCl) in people with Post Tonsillectomy Pain and Post Operative Analgesia, run by Ankara 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 5 inclusion and 11 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 13 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. 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?
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?
Postoperative NRS Score and Opioid Consumption (time frame: Postoperative 1. 2. 4. 8. 16. and 24. Hours). 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 NCT07370129, which also lists 26 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 13 Oct 2026.