Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain

NCT06121102 | Unknown

• 1 other identifier: 2203-301-013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulsed Radiofrequency; Super Voltage Pulsed Radiofrequency; Glossopharyngeal Nerve; Oropharyngeal Cancer; Pain

Outcome Measures

Primary Outcomes (1)

• The degree of pain

  Each patient will be instructed about pain assessment with the visual analog scale (VAS) score. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS score will be measured at the following times: pre-procedure, day 1 after the procedure, 1,2,3,4 Weeks after the procedure, 2,3 Months after the procedure.

  3 months after the procedure

Secondary Outcomes (5)

• Morphine consumption

  3 months after the procedure

• Gabapentin consumption

  3 months after the procedure

• Patient satisfaction score

  1 month after the block

• Percentage of functional improvement

  1 month after the procedure

• Quality of life score

  12 weeks after the procedure

Study Arms (2)

Group A (supervoltage pulsed radiofrequency glossopharyngeal nerve block)

EXPERIMENTAL

Patients will receive supervoltage pulsed radiofrequency glossopharyngeal nerve block.

Procedure: Supervoltage pulsed radiofrequency glossopharyngeal nerve block

Group B (standard voltage pulsed radiofrequency glossopharyngeal nerve block)

ACTIVE COMPARATOR

Patients will receive standard voltage pulsed radiofrequency glossopharyngeal nerve block.

Procedure: Standard voltage pulsed radiofrequency glossopharyngeal nerve block

Interventions

Supervoltage pulsed radiofrequency glossopharyngeal nerve block PROCEDURE

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.

Group A (supervoltage pulsed radiofrequency glossopharyngeal nerve block)

Standard voltage pulsed radiofrequency glossopharyngeal nerve block PROCEDURE

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.

Group B (standard voltage pulsed radiofrequency glossopharyngeal nerve block)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Cairo University

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Pain

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hany M Benyameen, Master

CONTACT

00201066972626; hanydanial2008@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 8, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)