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

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ClinicalTrials.gov Identifier: NCT04085120
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr.Dinesh Manoharan, 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

Condition or disease Intervention/treatment Phase
Cancer, Oropharynx Pain, Intractable Cancer Pain Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection Procedure: 10% lignocaine injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : February 28, 2020


Arm Intervention/treatment
Experimental: Ropivacaine/dexamethasone group
3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected.
Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection

Experimental: 10% lignocaine injection group
4 ml of 10% lignocaine
Procedure: 10% lignocaine injection
Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Brief Pain Inventory (BPI)- short form [ Time Frame: 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)

  2. WHO Quality of Life-BREF [ Time Frame: 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).

  3. Patient Global Impression of Change (PGIC) [ Time Frame: 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

  4. Clinical Global Impression of Change (CGIC) [ Time Frame: 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.

  5. Analgesic requirement and rescue analgesic requirement [ Time Frame: 4 weeks ]
    The number and dose of drugs before and after treatment will be assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. Local infection or skin ulceration at the puncture site
  2. Local anaesthetic allergy
  3. Psychiatric illness that affected cooperation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085120


Contacts
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Contact: Dinesh Manoharan, MD 918447857079 dineshkimi@gmail.com

Locations
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India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: DINESH MANOHARAN    8447857079    dineshkimi@gmail.com   
Principal Investigator: dinesh manoharan         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Principal Investigator: Dinesh Manoharan, MD All India Institute of Medical Sciences, New Delhi

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Responsible Party: Dr.Dinesh Manoharan, Senior Resident, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT04085120     History of Changes
Other Study ID Numbers: IEC-402/07.06.2019, RP-34/2019
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Cancer Pain
Pain, Intractable
Pain
Neurologic Manifestations
Signs and Symptoms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Dexamethasone
Dexamethasone acetate
Lidocaine
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents