Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 2:15 PM
Study NCT ID:
NCT04299035
Status:
UNKNOWN
Last Update Posted:
2020-03-06
First Post:
2020-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESP Block vs. Traditional Pain Management for ERAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Pain Score', 'timeFrame': '3 days', 'description': 'Reported immediate postoperative VAS score, up to 3rd day'}, {'measure': 'Total pain med consumption in the PACU', 'timeFrame': '3 hours', 'description': 'Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU'}, {'measure': 'Length of stay in the PACU', 'timeFrame': '24 hours', 'description': 'Length of stay in postoperative care room'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '30 days', 'description': 'Length of hospital stay'}, {'measure': 'Chronic pain development', 'timeFrame': '6 months', 'description': 'Rate of chronic pain at 3 and 6 months after surgery'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Erector spinae plane block'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome.\n\nTraditional pain management in these groups of patients - such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs - may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding.\n\nWe suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.\n\nExclusion Criteria:\n\n* Unconscious or mentally incompetent patients or those who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04299035', 'briefTitle': 'ESP Block vs. Traditional Pain Management for ERAS', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Erector Spinae Plane Block Versus Traditional Pain Management for Enhanced Recovery After Surgery', 'orgStudyIdInfo': {'id': '0355-19-SOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thoracic surgery + ESPblock', 'description': 'Thoracic surgery + ESPblock + standard pain management', 'interventionNames': ['Procedure: Erector spinae plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Abdominal surgery + ESPblock', 'description': 'Abdominal surgery + ESPblock + standard pain management', 'interventionNames': ['Procedure: Erector spinae plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal surgery + ESPblock', 'description': 'Spinal surgery + ESPblock + standard pain management', 'interventionNames': ['Procedure: Erector spinae plane block']}, {'type': 'NO_INTERVENTION', 'label': 'Thoracic surgery', 'description': 'Thoracic surgery + standard pain management'}, {'type': 'NO_INTERVENTION', 'label': 'Abdominal surgery', 'description': 'Abdominal surgery + standard pain management'}, {'type': 'NO_INTERVENTION', 'label': 'Spinal surgery', 'description': 'Spinal surgery + standard pain management'}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Erector spinae plane block', 'armGroupLabels': ['Abdominal surgery + ESPblock', 'Spinal surgery + ESPblock', 'Thoracic surgery + ESPblock']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Dmitry Natanel, MD', 'role': 'CONTACT', 'email': 'nataneld@bgu.ac.il', 'phone': '0533360451'}], 'facility': 'SorokaUMC', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Dmitry Natanel, MD', 'role': 'CONTACT', 'email': 'nataneld@bgu.ac.il', 'phone': '+972533360451'}, {'name': 'Michael Dubilet, MD', 'role': 'CONTACT', 'email': 'michaeldu@clalit.org.il'}], 'overallOfficials': [{'name': 'Michael Dubilet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dmitry Natanel MD', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}