Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-25 @ 1:44 PM
Study NCT ID:
NCT04102267
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Delivery of Bupivacaine Study in Herniorrhaphy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Total postoperative opioid consumption (in morphine equivalents)', 'timeFrame': '72 hours'}, {'measure': 'Proportion of subjects who are opioid-free', 'timeFrame': '72 hours'}, {'measure': 'Median time in hours to first opioid rescue medication', 'timeFrame': '72 hours'}, {'measure': 'Mean AUC0-72 of the NRS-R pain intensity scores.', 'timeFrame': '72 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['herniorrhaphy', 'inguinal hernia', 'hernia', 'hernia surgery', 'postoperative pain'], 'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia\n* Has an American Society of Anesthesiologists Physical Status of I, II, or III\n* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives.\n\nExclusion Criteria:\n\n* Had any prior inguinal hernia repair\n* Has a planned concurrent surgical procedure\n* Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain\n* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications\n* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.\n* Has taken any NSAIDs within least 10 days prior to the scheduled surgery\n* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting)\n* Has been administered bupivacaine within 5 days prior to the scheduled surgery.\n* Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.\n* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug\n* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments\n* Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C\n* Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments\n* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix\n* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.\n* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives\n* Has undergone 3 or more surgeries within 12 months\n* Has a body mass index (BMI) \\>39 kg/m2.'}, 'identificationModule': {'nctId': 'NCT04102267', 'briefTitle': 'Extended Delivery of Bupivacaine Study in Herniorrhaphy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heron Therapeutics'}, 'officialTitle': 'A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy', 'orgStudyIdInfo': {'id': 'BUPI-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposomal bupivacaine injection (Group 1)', 'description': 'Liposomal bupivacaine 266 mg via injection', 'interventionNames': ['Drug: Bupivacaine liposome injectable suspension']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine HCl continuous infusion (Group 2)', 'description': 'Bupivacaine HCl 300 mg via continuous infusion', 'interventionNames': ['Drug: Bupivacaine HCl without epinephrine via continuous infusion']}], 'interventions': [{'name': 'Bupivacaine liposome injectable suspension', 'type': 'DRUG', 'description': 'Liposomal bupivacaine 266 mg via injection', 'armGroupLabels': ['Liposomal bupivacaine injection (Group 1)']}, {'name': 'Bupivacaine HCl without epinephrine via continuous infusion', 'type': 'DRUG', 'description': 'Bupivacaine HCl 300 mg via continuous infusion', 'armGroupLabels': ['Bupivacaine HCl continuous infusion (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heron Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}