Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-29 @ 12:54 PM
Study NCT ID:
NCT05276258
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D009463', 'term': 'Neuroma'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Use Within 24 Hours After Chest Tube Removal', 'timeFrame': 'From the time of chest tube removal to 24 hours after chest tube removal', 'description': 'Opioid use measured as the daily dose of milligram morphine equivalents (MME)'}], 'secondaryOutcomes': [{'measure': 'Total Emergent Adverse Effects (TEAE)', 'timeFrame': 'Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery', 'description': 'Morbidity, defined as total emergent adverse effects (TEAE) for the experimental group vs. control'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'From admission to discharge or death, up to 1 year after surgery', 'description': 'Time spent in the hospital from admission for surgery until discharge or death'}, {'measure': 'Mean Cost of Hospital Care', 'timeFrame': 'From admission to discharge or death, up to 1 year after surgery', 'description': 'Total cost of billed medical care for the surgery'}, {'measure': 'Number of Readmissions', 'timeFrame': 'From initial admission for surgery to 28 days after surgery', 'description': 'The number of readmissions to the hospital'}, {'measure': 'Neuroma Formation', 'timeFrame': 'Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery', 'description': 'The formation of a neuroma around the site of nerve block administration'}, {'measure': 'Pain Score', 'timeFrame': 'Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery', 'description': "Patient's perceived pain level on a scale of 1 to 10"}, {'measure': 'PROMIS3a Pain Intensity', 'timeFrame': 'Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery', 'description': "Patient's perceived pain level on a scale of 3-15, per PROMIS Pain Intensity Short Form 3a v1.0"}, {'measure': 'PROMIS8a Pain Interference', 'timeFrame': 'Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery', 'description': "Patient's perceived pain interference level on a scale of 8-40, per PROMIS Pain Interference Adult Form"}, {'measure': 'Opioid Use after Surgery', 'timeFrame': 'Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery', 'description': 'Mean daily opioid use after surgery measured in milligram morphine equivalents (MME)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pain management', 'pulmonary surgical procedures', 'robotic surgical procedures', 'pneumonectomy', 'nerve block', 'neuroma', 'analgesics, opioid', 'bupivacaine', 'length of stay', 'drug tolerance'], 'conditions': ['Pain', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '29708130', 'type': 'BACKGROUND', 'citation': 'Goto T. What is the best pain control after thoracic surgery? J Thorac Dis. 2018 Mar;10(3):1335-1338. doi: 10.21037/jtd.2018.03.63. No abstract available.'}, {'pmid': '25912739', 'type': 'BACKGROUND', 'citation': 'Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.'}, {'pmid': '32038918', 'type': 'BACKGROUND', 'citation': 'Nobel TB, Adusumilli PS, Molena D. Opioid use and abuse following video-assisted thoracic surgery (VATS) or thoracotomy lung cancer surgery. Transl Lung Cancer Res. 2019 Dec;8(Suppl 4):S373-S377. doi: 10.21037/tlcr.2019.05.14. No abstract available.'}, {'pmid': '32142814', 'type': 'BACKGROUND', 'citation': 'Brown LM, Kratz A, Verba S, Tancredi D, Clauw DJ, Palmieri T, Williams D. Pain and Opioid Use After Thoracic Surgery: Where We Are and Where We Need To Go. Ann Thorac Surg. 2020 Jun;109(6):1638-1645. doi: 10.1016/j.athoracsur.2020.01.056. Epub 2020 Mar 3.'}, {'pmid': '29607171', 'type': 'BACKGROUND', 'citation': 'Kim MP, Chan EY, Meisenbach LM, Dumitru R, Brown JK, Masud FN. Enhanced recovery after thoracic surgery reduces discharge on highly dependent narcotics. J Thorac Dis. 2018 Feb;10(2):984-990. doi: 10.21037/jtd.2018.01.99.'}, {'type': 'BACKGROUND', 'citation': 'AtriCure, I., croSPHERE Probe Package Insert.'}, {'pmid': '30935731', 'type': 'BACKGROUND', 'citation': "Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17."}]}, 'descriptionModule': {'briefSummary': 'The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.', 'detailedDescription': "Patients who take more opioid medications after surgery tend to have longer hospital stays, and they are at risk of developing pneumonia and other postoperative morbidities. Opioid-tolerant patients are at a higher risk of developing these morbidities because they often require higher doses of opioid medications to manage their post-operative pain. Reducing post-operative pain in these patients through non-opioid means helps reduce their risk of developing morbidities, and is potentially a more effective form of pain management, particularly in this patient population.\n\nThis is a single-center, prospective cohort registry with a historical control, and an estimated duration of 2 years. This study's primary objective is to evaluate the cryoSPHERE probe for ablation in pain control after surgery (measured using opioid medication). The secondary objectives are the evaluation of morbidities, length of stay, cost, and incidence of neuroma formation.\n\nWe plan to recruit 75 patients who will receive the cryoSPHERE probe and compare them to 75 patients who did not receive the cryoSPHERE probe. The experimental group will receive cryoSPHERE ablation of intercostal nerves and liposomal bupivacaine. The historical control group will have had robotic-assisted thoracoscopic surgery and an intercostal nerve block with liposomal bupivacaine and no cyroSPHERE probe."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients 18-90 years of age\n* Diagnosis requiring robotic-assisted thoracoscopic surgery\n* Daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery or using opioids at the time of study enrollment\n* Experimental group only: agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact.\n\nExclusion Criteria:\n\n* Previous major surgery at the operative site (thoracotomy)\n* Allergy to aluminum\n* Allergy to plastics\n* Allergy to bupivacaine\n* Shingles disease\n* Demyelinating illnesses\n* Involvement with other interventional studies'}, 'identificationModule': {'nctId': 'NCT05276258', 'briefTitle': 'Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'A Randomized Controlled Trial of cryoSPHERE (CRYOS/CRYOS-L) Ablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients Undergoing Robotic-Assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': 'PRO00029370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation', 'description': 'The experimental group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine and the cryoSPHERE ablation of intercostal nerves during robotic-assisted thoracoscopic operation at Houston Methodist Hospital.', 'interventionNames': ['Device: cryoSPHERE Ablation', 'Drug: Bupivacaine']}, {'type': 'OTHER', 'label': 'Historical Controls', 'description': 'A total of 75 propensity score-matched historical controls will be selected from the pool of patients who had standard intercostal nerve block using liposomal bupivacaine alone at Houston Methodist Hospital from January 1, 2017 through January 1, 2022, inclusively.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'cryoSPHERE Ablation', 'type': 'DEVICE', 'otherNames': ['cryoSPHERE'], 'description': 'The cryoSPHERE probe will be introduced through a thoracoscopic port and placed inferior to each rib level and 2cm lateral and away from the sympathetic chain when clearly visible or 4cm lateral and away from the spine when the sympathetic chain is not visible. Levels to be ablated are intercostal spaces 3-9. Each intercostal nerve will undergo cryogenic ablation of -70 degrees Celsius for 120 seconds. The probe will be firmly pushed against the nerve for 120 seconds and will only be released from the nerve when the probe has thawed. Axons within the intercostal nerve that send pain signals will be destroyed distal to the cryoablation site. However, the tubules structures (epineurium, perineurium, and endoneurium) of the nerve will remain intact, allowing the axons to regenerate and nerve function to resume after one to three months.', 'armGroupLabels': ['Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['liposomal bupivacaine', 'Exparel'], 'description': 'A long needle will be introduced through a thoracoscopic port, and in each intercostal space (1-11), 1ml of liposomal bupivacaine will be injected onto the intercostal nerves to induce intercostal nerve blockage.', 'armGroupLabels': ['Historical Controls', 'Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Min Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor of Surgery', 'investigatorFullName': 'Min P. Kim, MD', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}