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

Not Applicable

• Conditions: Cancer, Oropharynx; Cancer Pain; Pain, Intractable
• Interventions: Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection; Procedure: 10% lignocaine injection

• Registration Number: NCT04085120
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-11
• Study Start: 2019-08-23
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-08
• Last Update Submitted: 2019-09-08
• Study First Posted: 2019-09-11
• Last Update Posted: 2019-09-11
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine/dexamethasone group	0.75 % Ropivacaine/ 4mg/mL dexamethasone injection	3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected.
10% lignocaine injection group	10% lignocaine injection	4 ml of 10% lignocaine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.
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
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).

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India