Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain

Cancer Pain Clinical Trial

Official title:

Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04085120
• Other study ID #: IEC-402/07.06.2019, RP-34/2019
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2019
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Dinesh Manoharan, MD
• Phone: 918447857079
• Email: dineshkimi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with proven carcinoma of the oropharynx and supraglottic larynx with estimated survival of 3 months or more.

• Pain lasting for at least 2 weeks with an average intensity of 5 or more on an 11-point numeric rating scale (NRS) refractory to a combination strong opioids and NSAIDS

Exclusion Criteria:

1. Local infection or skin ulceration at the puncture site

2. Local anaesthetic allergy

3. Psychiatric illness that affected cooperation.

Related Conditions & MeSH terms

• Cancer Pain
• Cancer, Oropharynx
• Oropharyngeal Neoplasms
• Pain, Intractable

Intervention

Procedure:
• 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
• 10% lignocaine injection
Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction on the basis of the Numeric rating scale (NRS).	Pain reduction on the basis of the Numeric rating scale (NRS). From 0 to 10 (No pain to highest pain)	4 weeks
Secondary	Brief Pain Inventory (BPI)- short form	BPI scores will be used to assess the change in pain before and after treatment. (Likert scale of 0 to 10, where 0 is none to 10 is maximum)	4 weeks
Secondary	WHO Quality of Life-BREF	WHO Quality of Life-BREF scores will be used to assess change in quality of life before and after treatment. (Likert scale of 0 to 5, where 0 is no interference to quality of life and 5 is maximum).	4 weeks
Secondary	Patient Global Impression of Change (PGIC)	Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC). A treatment success is defined as Much or Very Much Improved at the Week 4. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved	4 weeeks
Secondary	Clinical Global Impression of Change (CGIC)	Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) . A treatment success is defined as Much or Very Much Improved at the Week 4. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improve.	4 weeks
Secondary	Analgesic requirement and rescue analgesic requirement	The number and dose of drugs before and after treatment will be assessed.	4 weeks