1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [taru_ruchi@yahoo.co.in].
   


6. For how long will this data be available start date provided 06-08-2025 and end date provided 06-03-2030?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Project title: To evaluate the clinical performance of Laryngo-Tracheal Mucosal Atomizer versus cotton tipped swabs for administering transnasal pterygopalatine ganglion block in head and neck cancer patients: a randomized clinical trial.

Introduction

Patients with head and neck cancer (HNC) have the highest prevalence of pain among patients with cancer. Cancer is a dynamic process in which as the disease progresses; one can never get optimal pain relief with time. 80% develop pain during radiotherapy and chemotherapy.

Pterygopalatine ganglion block (PPGB) is an interventional procedure used to treat chronic head and neck pain like migraine, postdural puncture headache or trigeminal neuralgia etc. various studies have proved that PPGB provides excellent analgesia in different types of acute and chronic orofacial pain.

PPGB can be approached by the transnasal and transfacial routes. The transnasal approach is technically simple, quick, and has minimal side effects. Conventional methods of transnasal block require the use of an endoscope, image guidance, or a special catheter like Tx360, Sphenocath, Allevio. These atomizers are not available in our country and no studies are available on the last device with single study with former two. 

There are several studies on the successful use of cotton-tipped swabs in patients with migraine and post-dural puncture headache and an observational study in head and neck cancer patients. However, variability in anatomy amongst patients makes uncertain regarding drug delivery to ganglion thus high potential for misplaced and ineffective block. Also, as the mucosal area opposed to Cotton-tipped swabs is minimal thus may deliver an inaccurate dose of local anesthetic.

Laryngo-Tracheal Mucosal Atomization Device is long (12cm), narrow (4.8mm) tubular atomizer with stylet which can be gently curved and flexible, allowing it to adjust to any shape. It Atomizes drugs into a fine mist (30-100µm) and delivers particles at optimal size for rapid mucosal absorption. It has been used successfully for oro-pharyngeal and laryngeal anesthesia during awake fiberoptic intubation, but its practicality and clinical performance for ganglion blocks is not established.

MAD will spray LA superiorly, laterally and trickle downwards to bathe the ganglion, thus ensuring that anesthetic drug reaches the ganglion even in pts with varied anatomy. This technique thus accommodates varying anatomy, ensures that the LA reaches the ganglion.

It can be performed as quickly as 10 sec while cotton swabs need to be placed for 5-10 mts in the position.

Primary outcome -

1.Pain score (VAS) before intervention, after 15 minutes of administering block and then followed at 1 hour, 8 hours and 24 hours

Secondary outcome –

1.     Patient satisfaction score

2.     Rescue dose of Morphine taken by patient 24 hrs before and for breakthrough pain during 24 hours.

3.     Any other side effects associated with block like epistaxis etc

Total sample size = 140