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

All India Institute of Medical Sciences60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Cancer, Oropharynx Pain, Intractable Cancer Pain

Interventions

0.75 % Ropivacaine/ 4mg/mL dexamethasone injectionPROCEDURE

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

10% lignocaine injectionPROCEDURE

Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 4 weeks

Secondary Outcomes

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)

Time frame: 4 weeks

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).

Time frame: 4 weeks

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

Time frame: 4 weeeks

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.

Time frame: 4 weeks

Analgesic requirement and rescue analgesic requirement

The number and dose of drugs before and after treatment will be assessed.

Time frame: 4 weeks

Central Contacts

Dinesh Manoharan, MD

CONTACT

918447857079 dineshkimi@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.