Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-27 @ 8:07 PM
Study NCT ID:
NCT04807504
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropivacaine Pharmacokinetics in ESP Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean maximum plasma concentration of ropivacaine', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Mean pain scores', 'timeFrame': '24 hours', 'description': 'Numerical rating scale pain scores (0-10 where 0 is no pain and 10 is worst pain imaginable)'}, {'measure': 'Opioid consumption', 'timeFrame': '24 hours', 'description': 'Mean amount of opioids consumed in morphine milligram equivalents'}, {'measure': 'Sensory levels', 'timeFrame': '12 hours', 'description': 'Mean number of dermatomes blocked after erector spinae plane block'}, {'measure': 'Quality of recovery', 'timeFrame': '24 hours', 'description': 'The mean quality of recovery 15 survey scores (0-150 where 0 is worst quality of recovery and 150 is best)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Local Anesthetic Systemic Toxicity', 'Pain', 'Quality of Recovery']}, 'referencesModule': {'references': [{'pmid': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}, {'pmid': '16192762', 'type': 'BACKGROUND', 'citation': 'Karmakar MK, Ho AM, Law BK, Wong AS, Shafer SL, Gin T. Arterial and venous pharmacokinetics of ropivacaine with and without epinephrine after thoracic paravertebral block. Anesthesiology. 2005 Oct;103(4):704-11. doi: 10.1097/00000542-200510000-00008.'}, {'pmid': '9175963', 'type': 'BACKGROUND', 'citation': 'Knudsen K, Beckman Suurkula M, Blomberg S, Sjovall J, Edvardsson N. Central nervous and cardiovascular effects of i.v. infusions of ropivacaine, bupivacaine and placebo in volunteers. Br J Anaesth. 1997 May;78(5):507-14. doi: 10.1093/bja/78.5.507.'}, {'pmid': '29336785', 'type': 'BACKGROUND', 'citation': 'Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.'}, {'pmid': '37085287', 'type': 'DERIVED', 'citation': 'Schwenk ES, Lam E, Abulfathi AA, Schmidt S, Gebhart A, Witzeling SD, Mohamod D, Sarna RR, Roy AB, Zhao JL, Kaushal G, Rochani A, Baratta JL, Viscusi ER. Population pharmacokinetic and safety analysis of ropivacaine used for erector spinae plane blocks. Reg Anesth Pain Med. 2023 Sep;48(9):454-461. doi: 10.1136/rapm-2022-104252. Epub 2023 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a pharmacokinetic study to determine risk of local anesthetic systemic toxicity of ropivacaine when used in erector spinae plane blocks for thoracic surgery. Through serial blood sampling and the use of NONMEM population pharmacokinetic analysis this risk will be determined for the study population and other populations as well. Pain and quality of recovery will also be assessed.The erector spinae plane (ESP) block was first described in 2016 as a novel fascial plane block that provided analgesia for thoracic neuropathic pain. Since then hundreds of articles have been published that have reported use of the ESP block for indications such as rib fractures, breast surgery, abdominal surgery, and even shoulder surgery. It has also been studied in thoracic surgery and clinical experience confirms that patients undergoing video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracic surgery experience satisfactory analgesia with ESP blocks. Because the block location is further from the neuraxis than both epidural and paravertebral blocks, ESP blocks have been suggested as a safer alternative to these older blocks but safety data have not yet been generated. In particular, the risk of local anesthetic systemic toxicity (LAST) has not been studied in ESP blocks. While the pharmacokinetics of ropivacaine used for thoracic paravertebral blocks have been established, similar studies have yet to be performed for the newer ESP block. Of particular concern for ESP blocks are two factors not present in some other blocks with established safety: 1). significant intercostal spread has been noted in anatomical studies, which could put patients at risk for LAST and 2). some of the proposed dosing regimens involve the intermittent injection of large bolus doses of local anesthetic. While measurement of arterial plasma levels is useful and necessary to study the safety of ropivacaine given in ESP blocks, the measurements alone do not allow for prediction of plasma levels that would occur in populations as a whole. Nonmem is a population pharmacokinetic application that provides estimates of mean parameters and residual variability in pharmacokinetic values across populations and has been shown to generate better estimates than the two-stage approach. Nonmem will be used in this study to predict pharmacokinetics in populations with different characteristics than the one being studied here, which would create generalizable results.', 'detailedDescription': 'The erector spinae plane (ESP) block was first described in 2016 as a novel fascial plane block that provided analgesia for thoracic neuropathic pain. Since then hundreds of articles have been published that have reported use of the ESP block for indications such as rib fractures, breast surgery, abdominal surgery, and even shoulder surgery. It has also been studied in thoracic surgery and our clinical experience confirms that patients undergoing video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracic surgery experience satisfactory analgesia with ESP blocks. Because the block location is further from the neuraxis than both epidural and paravertebral blocks, ESP blocks have been suggested as a safer alternative to these older blocks but safety data have not yet been generated. In particular, the risk of local anesthetic systemic toxicity (LAST) has not been studied in ESP blocks. While the pharmacokinetics of ropivacaine used for thoracic paravertebral blocks have been established, similar studies have yet to be performed for the newer ESP block. Of particular concern for ESP blocks are two factors not present in some other blocks with established safety: 1). significant intercostal spread has been noted in anatomical studies, which could put patients at risk for LAST and 2). some of the proposed dosing regimens involve the intermittent injection of large bolus doses of local anesthetic. While measurement of arterial plasma levels is useful and necessary to study the safety of ropivacaine given in ESP blocks, the measurements alone do not allow for prediction of plasma levels that would occur in populations as a whole. Nonmem is a population pharmacokinetic application that provides estimates of mean parameters and residual variability in pharmacokinetic values across populations and has been shown to generate better estimates than the two-stage approach. Nonmem will be used in this study to predict pharmacokinetics in populations with different characteristics than the one being studied here, which would create generalizable results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with lung cancer, recurrent pneumothoraces, or other condition requiring robotic or video-assisted thoracic surgery are eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing robotic or video-assisted thoracic surgery\n* able to speak English\n\nExclusion Criteria:\n\n* active liver disease\n* active renal disease\n* ropivacaine allergy'}, 'identificationModule': {'nctId': 'NCT04807504', 'briefTitle': 'Ropivacaine Pharmacokinetics in ESP Blocks', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Safety Study of Ropivacaine Concentrations During Continuous Erector Spinae Plane Block for Thoracic Surgery', 'orgStudyIdInfo': {'id': '20G.754'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'description': 'All patients receive erector spinae plane blocks with ropivacaine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Eric S Schwenk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Sidney Kimmel Medical College at Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual data will be shared de-identified upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}