Cancer, Oropharynx, Cancer Pain, Pain, Intractable
Conditions
Brief 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
Interventions
PROCEDURE0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
PROCEDURE10% lignocaine injection
Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction on the basis of the Numeric rating scale (NRS). | 4 weeks | Pain reduction on the basis of the Numeric rating scale (NRS). From 0 to 10 (No pain to highest pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI)- short form | 4 weeks | 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) |
| WHO Quality of Life-BREF | 4 weeks | 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). |
| Patient Global Impression of Change (PGIC) | 4 weeeks | 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 |
| Clinical Global Impression of Change (CGIC) | 4 weeks | 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. |
| Analgesic requirement and rescue analgesic requirement | 4 weeks | The number and dose of drugs before and after treatment will be assessed. |
Countries
India
Contacts
Primary ContactDinesh Manoharan, MD
Outcome results
None listed