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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine/dexamethasone group | Experimental | 3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected. |
|
| 10% lignocaine injection group | Experimental | 4 ml of 10% lignocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection | Procedure | Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dinesh Manoharan, MD | Contact | 918447857079 | dineshkimi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dinesh Manoharan, MD | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D010148 | Pain, Intractable |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002123 | Calcium Dobesilate |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 10% lignocaine injection | Procedure | Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection |
|
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 |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000083 | Acetanilides |