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

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

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

Conditions
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Cancer, Oropharynx, Pain, Intractable, Cancer Pain

Intervention / Treatment
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* Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
* Procedure: 10% lignocaine injection


Participation Criteria
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Eligibility Criteria
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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: Local infection or skin ulceration at the puncture site Local anaesthetic allergy Psychiatric illness that affected cooperation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine/dexamethasone group<br>3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected. | Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection<br>* Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection<br>|
| Experimental: 10% lignocaine injection group<br>4 ml of 10% lignocaine | Procedure: 10% lignocaine injection<br>* Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Analgesic requirement and rescue analgesic requirement | The number and dose of drugs before and after treatment will be assessed. | 4 weeks |