Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-28 @ 4:13 AM
Study NCT ID:
NCT05044468
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global chest pain score', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Will be evaluated by the Global chest pain score at the time of discharge from recovery area using a Visual Analog Scale 0-100 and represents the pain experienced by the patient.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Pleural Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial investigates the effect of EXPAREL compared to lidocane as a local anesthetic in patients who are undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. This trial aims to see whether EXPAREL or lidocane is able to make patients more comfortable.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To compare Global chest pain score (measured on the Visual Analog Scale \\[VAS\\] scale) post-procedure and post procedural chest pain (measured on the numerical rating scale), at the time of discharge from recovery between liposomal bupivacaine (EXPAREL) and 1 percent lidocaine.\n\nSECONDARY OBJECTIVES:\n\nI. To compare post procedural chest pain (measured on the numerical rating scale) at the time of discharge from recovery, 24 hours and 48 hours post procedure between EXPAREL and 1 percent lidocaine.\n\nII. To assess the change in global chest pain score (measured on the VAS scale) from baseline to the time of discharge from recovery, and post procedural chest pain (measured on the numerical rating scale) from baseline over time between EXPAREL and 1 percent lidocaine.\n\nIII. To compare the number of narcotics within 24 hours, and from 24 to 48 hours post procedure between EXPAREL and 1 percent lidocaine.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP A: Patients receive liposomal bupivacaine via injection into the intercostal nerve block.\n\nGROUP B: Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement\n2. Age \\> 18\n\nExclusion criteria:\n\n1. Inability to provide informed consent\n2. Study subject has any disease or condition that interferes with safe completion of the study including:\n\n a. Allergic reaction to EXPAREL\n3. Need for pleurodesis\n4. Allergies to lidocaine or other local anesthetics.\n5. Pregnancy\n6. Advanced liver disease where the clinician deems the procedure unsafe'}, 'identificationModule': {'nctId': 'NCT05044468', 'briefTitle': 'EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Randomized Blinded Controlled Trial of EXPAREL vs 1% Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement', 'orgStudyIdInfo': {'id': '2019-0237'}, 'secondaryIdInfos': [{'id': 'NCI-2021-08954', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2019-0237', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (liposomal bupivacaine)', 'description': 'Patients receive liposomal bupivacaine via injection into the intercostal nerve block.', 'interventionNames': ['Drug: Liposomal Bupivacaine', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (lidocaine)', 'description': 'Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.', 'interventionNames': ['Drug: Lidocaine', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['.omega.-Diethylamino-2,6-dimethylacetanilide', "2-(Diethylamino)-2'',6''-acetoxylidide", 'Cuivasil', 'Duncaine', 'Leostesin', 'Lidothesin', 'Lignocaine', 'Rucaina'], 'description': 'Given via injection', 'armGroupLabels': ['Group B (lidocaine)']}, {'name': 'Liposomal Bupivacaine', 'type': 'DRUG', 'otherNames': ['Bupivacaine Liposome Injectable Suspension', 'Exparel'], 'description': 'Given via injection', 'armGroupLabels': ['Group A (liposomal bupivacaine)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group A (liposomal bupivacaine)', 'Group B (lidocaine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Horiana Grosu', 'role': 'CONTACT', 'email': 'hbgrosu@mdanderson.org', 'phone': '713-792-6238'}, {'name': 'Horiana Grosu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Horiana Grosu, MD', 'role': 'CONTACT', 'email': 'hbgrosu@mdanderson.org', 'phone': '713-792-6238'}], 'overallOfficials': [{'name': 'Horiana Grosu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}