Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-07 @ 2:52 AM
Study NCT ID:
NCT04085120
Status:
UNKNOWN
Last Update Posted:
2019-09-11
First Post:
2019-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D010148', 'term': 'Pain, Intractable'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-08', 'studyFirstSubmitDate': '2019-08-11', 'studyFirstSubmitQcDate': '2019-09-08', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reduction on the basis of the Numeric rating scale (NRS).', 'timeFrame': '4 weeks', 'description': 'Pain reduction on the basis of the Numeric rating scale (NRS). From 0 to 10 (No pain to highest pain)'}], 'secondaryOutcomes': [{'measure': 'Brief Pain Inventory (BPI)- short form', 'timeFrame': '4 weeks', '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)'}, {'measure': 'WHO Quality of Life-BREF', 'timeFrame': '4 weeks', '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).'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': '4 weeeks', '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'}, {'measure': 'Clinical Global Impression of Change (CGIC)', 'timeFrame': '4 weeks', '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.'}, {'measure': 'Analgesic requirement and rescue analgesic requirement', 'timeFrame': '4 weeks', 'description': 'The number and dose of drugs before and after treatment will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer, Oropharynx', 'Pain, Intractable', 'Cancer Pain']}, 'descriptionModule': {'briefSummary': 'The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with proven carcinoma of the oropharynx and supraglottic larynx with estimated survival of 3 months or more.\n* 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\n\nExclusion Criteria:\n\n1. Local infection or skin ulceration at the puncture site\n2. Local anaesthetic allergy\n3. Psychiatric illness that affected cooperation.'}, 'identificationModule': {'nctId': 'NCT04085120', 'briefTitle': 'Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences'}, 'officialTitle': 'Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial', 'orgStudyIdInfo': {'id': 'IEC-402/07.06.2019, RP-34/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine/dexamethasone group', 'description': '3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected.', 'interventionNames': ['Procedure: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection']}, {'type': 'EXPERIMENTAL', 'label': '10% lignocaine injection group', 'description': '4 ml of 10% lignocaine', 'interventionNames': ['Procedure: 10% lignocaine injection']}], 'interventions': [{'name': '0.75 % Ropivacaine/ 4mg/mL dexamethasone injection', 'type': 'PROCEDURE', 'description': 'Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection', 'armGroupLabels': ['Ropivacaine/dexamethasone group']}, {'name': '10% lignocaine injection', 'type': 'PROCEDURE', 'description': 'Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection', 'armGroupLabels': ['10% lignocaine injection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110029', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'DINESH MANOHARAN', 'role': 'CONTACT', 'email': 'dineshkimi@gmail.com', 'phone': '8447857079'}, {'name': 'dinesh manoharan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Dinesh Manoharan, MD', 'role': 'CONTACT', 'email': 'dineshkimi@gmail.com', 'phone': '918447857079'}], 'overallOfficials': [{'name': 'Dinesh Manoharan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'All India Institute of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Resident', 'investigatorFullName': 'Dr.Dinesh Manoharan', 'investigatorAffiliation': 'All India Institute of Medical Sciences'}}}}