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Trial Title:
Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain
NCT ID:
NCT06121102
Condition:
Pulsed Radiofrequency
Super Voltage Pulsed Radiofrequency
Glossopharyngeal Nerve
Oropharyngeal Cancer
Pain
Conditions: Official terms:
Oropharyngeal Neoplasms
Cancer Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Supervoltage pulsed radiofrequency glossopharyngeal nerve block
Description:
Stimulation will be done using baylis generator both sensory at 50 HZ and 0.5-1.0 V
(patient felt tingling at base of tongue, throat, ear and side of upper neck) and motor
at 2 HZ and 1-2 V (contraction of stylopharyngeus muscle will be felt). After injecting 1
ml lidocaine 2% plus 1 ml (4 mg) Betamethasone (Diprofos) to augment analgesia and to
lower impedance (usually it was 200-300 ohm due to bony proximity).Super voltage pulsed
RF(60-75 volt according to patient tolerability will be done for 8 minutes with pulse
width = 5 millisecond and pulse frequency of 2 HZ.
Arm group label:
Group A (supervoltage pulsed radiofrequency glossopharyngeal nerve block)
Intervention type:
Procedure
Intervention name:
Standard voltage pulsed radiofrequency glossopharyngeal nerve block
Description:
Stimulation will be done using baylis generator both sensory at 50 HZ and 0.5-1.0 V
(patient felt tingling at base of tongue, throat, ear and side of upper neck) and motor
at 2 HZ and 1-2 V (contraction of stylopharyngeus muscle will be felt). After injecting 1
ml lidocaine 2% plus 1 ml (4 mg) Betamethasone (Diprofos) to augment analgesia and to
lower impedance (usually it was 200-300 ohm due to bony proximity).Super voltage8 pulsed
RF will be done for 8 minutes with pulse width = 5 millisecond and pulse frequency of 2
HZ.
Arm group label:
Group B (standard voltage pulsed radiofrequency glossopharyngeal nerve block)
Summary:
The aim of this study is to evaluate the safety and efficacy of supervoltage pulsed
radiofrequency glossopharyngeal nerve therapy versus standard pulsed radiofrequency in
reduction of oropharyngeal cancer pain, through Visual analog scale score reduction.
Detailed description:
The glossopharyngeal nerve is the 9th cranial nerve. It has motor, sensory and
parasympathetic function like trigeminal and facial nerves. It has its origin in the
medulla oblongata and exits the skull via the jugular foramen, close to vagus and
accessory nerves, together with the internal carotid artery and sympathetic nerves and
terminates in the pharynx between the superior and middle pharyngeal constrictors,
splitting into its terminal branches - lingual, pharyngeal, and tonsillar.
Glossopharyngeal neuralgia is an extremely uncommon occurrence and accounts for only
0.2%-1.3% of the cases with facial pain. It usually affects the male individuals above
50-year age, and the reported incidence of glossopharyngeal neuralgia is roughly 0.8 per
100,000 persons per year. As per ICHD-3 (International Classification of Headache
Disease- 3) classification, glossopharyngeal neuralgia is a disease characterized by an
episodic unilateral pain, with sharp and stabbing in character, with sudden onset and
cessation, in the glossopharyngeal nerve distribution (jaw angle, ear, tonsillar fossa
and the base of the tongue). It also affect the pharyngeal and auricular branches of the
vagus nerve. Pain is commonly aggravated by coughing, talking, and swallowing. Pain in
glossopharyngeal neuralgia has a relapsing and remitting pattern. Vaso glossopharyngeal
neuralgia may be associated with life-threatening cardiovascular features- syncope,
hypotension, cardiac arrhythmias, in contrast to trigeminal neuralgia
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 and ≤ 70 Years.
- Both sexes
- American Society of Anesthesiologists (ASA) class II and III.
- Patients under pain management for oropharyngeal cancer (failed medical treatment or
intolerance to the side effects of the drug).
- Visual analog scale (VAS) equal to or more than 6 cm in spite medical treatment.
Exclusion Criteria:
- Patient refusal.
- Patients with local or systemic sepsis.
- Uncorrectable coagulopathy.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.7
- Unable to lie supine.
- Local anatomical distortion (either congenital, post-surgical or post-radiotherapy)
making intervention difficult and hazardous.
- Elongated styloid process > 25 mm.
- Age less than 18 year and more than 70 year.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cairo University
Address:
City:
Cairo
Zip:
11796
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Hany M Benyameen, Master
Phone:
00201066972626
Email:
hanydanial2008@gmail.com
Investigator:
Last name:
Emad G Saleh, MD
Email:
Sub-Investigator
Investigator:
Last name:
Raafat M Reyad, MD
Email:
Sub-Investigator
Investigator:
Last name:
Fady S Saad, MD
Email:
Sub-Investigator
Start date:
November 8, 2023
Completion date:
April 1, 2024
Lead sponsor:
Agency:
National Cancer Institute, Egypt
Agency class:
Other
Source:
National Cancer Institute, Egypt
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06121102
