Transnasal Sphenopalatine Ganglion Block for Postoperative Pain and Recovery in Tonsillectomy (TONwoPA) (TONwoPA)

January 19, 2026 updated by: Sıddık Aytuğ, Ankara University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06180
        • Ankara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Lidocain
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).
Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block
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.
Procedure: Lidocaine %5
Transnasal Transmucosal Sphenopalatine Ganglion Block with Lidocaine %5
Sham Comparator: Group Saline
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).
Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block
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.
Procedure: Saline (0.9% NaCl)
Transnasal Transmucosal Sphenopalatine Ganglion Block with Saline (0.9% NaCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 1. 2. 4. 8. 16. and 24. Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameters for Postoperative Complications and Recovery Process
Time Frame: Postoperative 14th Day
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.
Postoperative 14th Day
Feeding Tolerance and Time to First Tolerated Oral Intake
Time Frame: Postoperative 1.2.4.8.16. and 24. Hours
The timing of the patient's first oral intake of liquids and solids, and any accompanying pain, will also be monitored.
Postoperative 1.2.4.8.16. and 24. Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Chair: İbrahim Aşık, Professor, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025000458
  • 25-AKD-116 (Registry Identifier: Turkish Medicines and Medical Devices Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study was not designed with a data-sharing plan and to ensure participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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