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

NCT07370129 | Enrolling By Invitation

• 2 other identifiers: 202500045825-AKD-116
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative 1. 2. 4. 8. 16. and 24. Hours

Secondary Outcomes (2)

• Parameters for Postoperative Complications and Recovery Process

  Postoperative 14th Day

• Feeding Tolerance and Time to First Tolerated Oral Intake

  Postoperative 1.2.4.8.16. and 24. Hours

Study Arms (2)

Group Lidocain

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).

Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block; Procedure: Lidocaine %5

Group Saline

SHAM 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).

Procedure: Transnasal Transmucosal Sphenopalatine Ganglion Block; Procedure: Saline (0.9% NaCl)

Interventions

Transnasal Transmucosal Sphenopalatine Ganglion Block PROCEDURE

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.

Group Lidocain; Group Saline

Lidocaine %5 PROCEDURE

Transnasal Transmucosal Sphenopalatine Ganglion Block with Lidocaine %5

Group Lidocain

Saline (0.9% NaCl) PROCEDURE

Transnasal Transmucosal Sphenopalatine Ganglion Block with Saline (0.9% NaCl)

Group Saline

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Ankara, 06180, Turkey (Türkiye)

Location

Related Publications (26)

• Nelson Textbook of Pediatrics Twenty Second Edition Pediatric Pain Management Nelson Textbook of Pediatrics, Chapter 93, 677-700.e2

  BACKGROUND

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• Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial British Journal of Anaesthesia, 124 (6): 739e747 (2020) doi: 10.1016/j.bja.2020.02.025

  BACKGROUND

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  PMID: 28120104 BACKGROUND

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  PMID: 17578986 BACKGROUND

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MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• İbrahim Aşık, Professor

  Ankara University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Sıddık Aytuğ Medical Resident

Model Details: A randomized, placebo-controlled interventional clinical study

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)