Cancer, OropharynxNCT04085120
Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain
A study testing 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection and 10% lignocaine injection in people with Cancer, Oropharynx and Pain, Intractable, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Oropharynx, Pain, Intractable, Cancer Pain
- What is being tested?
- 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection and 10% lignocaine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 23 Aug 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Local infection or skin ulceration at the puncture site
- Local anaesthetic allergy
- Psychiatric illness that affected cooperation.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
DINESH MANOHARAN, 8447857079, dineshkimi@gmail.com
dinesh manoharan
About this study
Official title: Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial
The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain
- Conditions
- Cancer, Oropharynx, Pain, Intractable, Cancer Pain
- Being tested
- 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection, 10% lignocaine injection
- Medical subject headings
- Oropharyngeal Neoplasms, Pain, Intractable, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75 % Ropivacaine/ 4mg/mL dexamethasone injectionProcedure or surgery
Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
10% lignocaine injectionProcedure or surgery
Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine/dexamethasone group | Experimental | 3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected. Receives: Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection |
| 10% lignocaine injection group | Experimental | 4 ml of 10% lignocaine Receives: Procedure: 10% lignocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (5)
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)
Measured: 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).
Measured: 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
Measured: 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.
Measured: 4 weeks
Analgesic requirement and rescue analgesic requirement
The number and dose of drugs before and after treatment will be assessed.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start23 Aug 2019
- Primary completion31 Jan 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, OropharynxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Dinesh Manoharan, All India Institute of Medical Sciences
- Investigators
- Dinesh Manoharan, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085120
- Sponsor's protocol ID
- IEC-402/07.06.2019, RP-34/2019
- Status last verified
- Sep 2019
- First submitted
- 11 Aug 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial
- ClinicalTrials.gov ID
- NCT04085120
- Acronym / sponsor ID
- IEC-402/07.06.2019, RP-34/2019
- Conditions
- Cancer, Oropharynx, Pain, Intractable, Cancer Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine/dexamethasone group | Experimental | Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected. |
| 10% lignocaine injection group | Experimental | Procedure: 10% lignocaine injection4 ml of 10% lignocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Local infection or skin ulceration at the puncture site
- Local anaesthetic allergy
- Psychiatric illness that affected cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.75 % Ropivacaine/ 4mg/mL dexamethasone injectionDistal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection | Procedure or surgery | Ropivacaine/dexamethasone group |
| 10% lignocaine injectionDistal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection | Procedure or surgery | 10% lignocaine injection group |
Primary outcome
Pain reduction on the basis of the Numeric rating scale (NRS).
Time frame: 4 weeks
Pain reduction on the basis of the Numeric rating scale (NRS). From 0 to 10 (No pain to highest pain)
5 secondary outcomes
Brief Pain Inventory (BPI)- short form
Time frame: 4 weeks
WHO Quality of Life-BREF
Time frame: 4 weeks
Patient Global Impression of Change (PGIC)
Time frame: 4 weeeks
Clinical Global Impression of Change (CGIC)
Time frame: 4 weeks
Analgesic requirement and rescue analgesic requirement
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer, Oropharynx
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinesh Manoharan, MD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection and 10% lignocaine injection in people with Cancer, Oropharynx and Pain, Intractable, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dinesh Manoharan, MD (918447857079, dineshkimi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction on the basis of the Numeric rating scale (NRS). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.