Back to resultsRopivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain
Primary Purpose
Cancer, Oropharynx, Pain, Intractable, Cancer Pain
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
10% lignocaine injection
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer, Oropharynx
Eligibility Criteria
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.
Sites / Locations
- All India Institute of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ropivacaine/dexamethasone group
10% lignocaine injection group
Arm Description
3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected.
4 ml of 10% lignocaine
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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).
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
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.
Analgesic requirement and rescue analgesic requirement
The number and dose of drugs before and after treatment will be assessed.
Full Information
NCT ID
NCT04085120
First Posted
August 11, 2019
Last Updated
September 8, 2019
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT04085120
Brief Title
Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain
Official Title
Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Oropharynx, Pain, Intractable, Cancer Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine/dexamethasone group
Arm Type
Experimental
Arm Description
3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected.
Arm Title
10% lignocaine injection group
Arm Type
Experimental
Arm Description
4 ml of 10% lignocaine
Intervention Type
Procedure
Intervention Name(s)
0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
Intervention Description
Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
Intervention Type
Procedure
Intervention Name(s)
10% lignocaine injection
Intervention Description
Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection
Primary Outcome Measure Information:
Title
Pain reduction on the basis of the Numeric rating scale (NRS).
Description
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 Outcome Measure Information:
Title
Brief Pain Inventory (BPI)- short form
Description
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
Title
WHO Quality of Life-BREF
Description
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
Title
Patient Global Impression of Change (PGIC)
Description
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
Title
Clinical Global Impression of Change (CGIC)
Description
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
Title
Analgesic requirement and rescue analgesic requirement
Description
The number and dose of drugs before and after treatment will be assessed.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dinesh Manoharan, MD
Phone
918447857079
Email
dineshkimi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinesh Manoharan, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DINESH MANOHARAN
Phone
8447857079
Email
dineshkimi@gmail.com
First Name & Middle Initial & Last Name & Degree
dinesh manoharan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain
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