Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT03592056
Status:
TERMINATED
Last Update Posted:
2020-01-23
First Post:
2018-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012133', 'term': 'Respiratory Paralysis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'interim analysis proved that protocol intervention had no preventive effect', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemidiaphragmatic paralysis before discharge', 'timeFrame': '24 hours after surgery', 'description': 'Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Hemidiaphragmatic paralysis after surgery', 'timeFrame': '30 minutes after arrival to post anesthetic care unit (PACU)', 'description': 'Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography'}, {'measure': 'Amount of local anesthetic (LA) boluses used before discharge.', 'timeFrame': '24 hours after surgery', 'description': 'boluses of LA administered by the patient controlled infusor in adidiotn to a basal rate.'}, {'measure': 'Level of static postoperative pain at 30 minutes of arrival to PACU', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'Level of static postoperative pain 1 hour after arrival to PACU', 'timeFrame': '60 minutes after arrival', 'description': 'level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'Level of static postoperative pain 3 hour after arrival to PACU', 'timeFrame': '3 hours after arrival to PACU', 'description': 'level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'level of static pain 6 hours after arrival to PACU', 'timeFrame': '6 hours after arrival to PACU', 'description': 'level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'Level of static pain 12 hours after arrival to PACU', 'timeFrame': '12 hour after arrival to PACU', 'description': 'Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'Level of static pain before discharge', 'timeFrame': '24 hours post surgery', 'description': 'Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'Level of static pain during first day after the day of discharge', 'timeFrame': '48 hours after surgery', 'description': 'Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'Level of static pain during second day after the day of discharge', 'timeFrame': '72 hours after surgery', 'description': 'Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10'}, {'measure': 'intraoperative morphine equivalent consumption', 'timeFrame': 'intraoperative period', 'description': 'total amount of morphine equivalent opioid requirement in milligrams'}, {'measure': 'postoperative morphine equivalent consumption', 'timeFrame': '24 hours after surgery', 'description': 'total amount of morphine equivalent opioid requirement in milligrams'}, {'measure': 'sensory block in PACU', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'loss of sensation to cold in lateral deltoid area'}, {'measure': 'Motor block in PACU', 'timeFrame': '30 minutes after arrival to PACU', 'description': 'paresia or paralysis in operated side, shoulder, arm, forearm or hand'}, {'measure': 'sensory block previous to discharge', 'timeFrame': '24 hours after surgery', 'description': 'loss of sensation to cold in lateral deltoid area'}, {'measure': 'motor block previous to discharge', 'timeFrame': '24 hours after surgery', 'description': 'paresia or paralysis in operated side shoulder, arm, forearm or hand'}, {'measure': 'Incidence of side effects before discharge', 'timeFrame': '24 hours after surgery', 'description': 'presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block.'}, {'measure': 'incidence of side effects after discharge with ambulatory continuous ISB.', 'timeFrame': '24 to 72 hours after surgery', 'description': 'presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemidiaphragmatic paralysis', 'continuous plexus block', 'interscalene plexus block', 'diluted local anesthetic infusion', 'ambulatory regional analgesia', 'ambulatory continuous nerve block', 'continuous local anesthetic infusion'], 'conditions': ['Diaphragmatic Paralysis', 'Postoperative Pain', 'Acute Pain', 'Shoulder Pain', 'Shoulder Injury']}, 'referencesModule': {'references': [{'pmid': '27941477', 'type': 'RESULT', 'citation': 'Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.'}, {'pmid': '26216250', 'type': 'RESULT', 'citation': 'Choromanski DW, Patel PS, Frederick JM, Lemos SE, Chidiac EJ. The effect of continuous interscalene brachial plexus block with 0.125% bupivacaine vs 0.2% ropivacaine on pain relief, diaphragmatic motility, and ventilatory function. J Clin Anesth. 2015 Dec;27(8):619-26. doi: 10.1016/j.jclinane.2015.03.006. Epub 2015 Jul 26.'}, {'pmid': '19608563', 'type': 'RESULT', 'citation': 'Fredrickson MJ, Price DJ. Analgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ultrasound-guided C5-6 root/superior trunk perineural ambulatory catheter. Br J Anaesth. 2009 Sep;103(3):434-9. doi: 10.1093/bja/aep195. Epub 2009 Jul 16.'}, {'pmid': '16331304', 'type': 'RESULT', 'citation': 'Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'Interscalene brachial plexus block (ISB) constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. Continuous ISBs have not avoided this complication with the reported and regularly used local anesthetic dilutions (i.e. 0.125% bupivacaine, 0.25% ropivacaine, etc). This observational study will register the incidence of HDP in continuous interscalene block (CISB) using a very diluted solution of levobupivacaine (0.04%) in patients undergoing arthroscopic shoulder surgery.\n\nThe main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing arthroscopic shoulder surgery and programmed to receive a continuous interscalene block as part of postoperative analgesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 80 years\n* American Society of Anesthesiologists classification 1-3\n* body mass index between 20 and 35\n\nExclusion Criteria:\n\n* adults who are unable to give their own consent\n* pre-existing neuropathy (assessed by history and physical examination)\n* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)\n* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)\n* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)\n* allergy to local anesthetics (LAs)\n* pregnancy\n* prior surgery in the ipsilateral neck region\n* chronic pain conditions'}, 'identificationModule': {'nctId': 'NCT03592056', 'briefTitle': 'Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions', 'organization': {'class': 'OTHER', 'fullName': 'Clinica las Condes, Chile'}, 'officialTitle': 'Incidence of Hemidiaphragmatic Paralysis Using 0.04% Levobupivacaine for Continuous Interscalene Brachial Plexus Blocks in Arthroscopic Shoulder Surgeries', 'orgStudyIdInfo': {'id': 'MA012018'}}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'Metropolitan', 'country': 'Chile', 'facility': 'Clínica Las Condes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica las Condes, Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiololgist, Clinical Instructor', 'investigatorFullName': 'Julián Aliste', 'investigatorAffiliation': 'Clinica las Condes, Chile'}}}}