Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT05337956
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2022-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Erector Spinae Plane Block Using Catheter for Video-assisted Thoracoscopy
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-16', 'studyFirstSubmitDate': '2022-03-12', 'studyFirstSubmitQcDate': '2022-04-16', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hours opioid consumption', 'timeFrame': '24 hours', 'description': 'How much opioid (morphine equivalents) in milligrams was consumed in 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Numerical rating score (NRS) pain score at 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours after surgery both at rest and when coughing', 'timeFrame': 'first 24 hours', 'description': 'Pain score measure by NRS pain score in postoperative period'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': '24 hours', 'description': 'The incidence and severity of postoperative nausea and vomiting'}, {'measure': 'Postoperative shoulder pain', 'timeFrame': '24 hours', 'description': 'Any complaint of Pain in shoulder in postoperative period will be recorded'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae block', 'Video-assisted thoracoscopy'], 'conditions': ['Post Operative Pain', 'Opioid Use']}, 'descriptionModule': {'briefSummary': 'Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc.\n\nErector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The aim of this study is to evaluate the effect of ESPB using catheter on postoperative 24 hours opioid consumption in video-assisted thoracoscopy (VATS)', 'detailedDescription': 'Video-assisted thoracoscopic surgery (VATS) is more commonly used technique nowadays in thoracic surgery. This technique is associated with lesser postoperative pain, better postoperative pulmonary function, decreased mortality and shorter hospital stay. However, patients can have severe and prolonged postoperative pain following VATS. Homma et al reported that 18.8 % of patients have persistent pain following VATS. Acute postoperative pain is considered to be one of strong predictor of persistent pain postoperatively.\n\nDifferent modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc.\n\nErector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The objective of this study is to investigate the role of ESPB using catheter in reducing opioid requirements in first 24 hours after VATS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged 18-70 years, ASA 1 to 3 undergoing video-assisted thoracoscopy\n\nExclusion Criteria:\n\n* Patient refusal, Contraindication to regional anesthesia, Allergy to local anesthesia, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate PCA, psychiatric disorders or use of psychiatric medications, conversion to open thoracotomy'}, 'identificationModule': {'nctId': 'NCT05337956', 'briefTitle': 'Ultrasound-guided Erector Spinae Plane Block Using Catheter for Video-assisted Thoracoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Security Forces Hospital'}, 'officialTitle': 'Evaluation of the Ultrasound-guided Erector Spinae Plane Block Using Catheter for Postoperative Analgesia in Video-assisted Thoracoscopy: A Prospective, Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'SFH-ESPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESPB catheter group', 'description': 'Patient in this group will receive ESP block', 'interventionNames': ['Procedure: Erector spinae plane block catheter']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patient in this group will not receive any block'}], 'interventions': [{'name': 'Erector spinae plane block catheter', 'type': 'PROCEDURE', 'description': 'All ESP blocks will be performed in lateral position after general anesthesia induction. ESPB will be performed under ultrasonographic guidance using a linear 6- to 10-MHz ultrasound probe. The linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T6-10 spinous process. The erector spinae muscles will be identified superficial to the tip of the transverse process. A 21-gauge 10-cm needle will be inserted using an in-plane superior-to-inferior approach or an out of plane approach. The tip of the needle will be placed into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on Ultrasonographic imaging. A total of 10-15 ml of 0.2% ropivacaine will be injected each side. A catheter will then be placed leaving 5 cm in place.', 'armGroupLabels': ['ESPB catheter group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Security Forces Hospital Program', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Anwar ul Huda, FRCA', 'role': 'CONTACT', 'email': 'hudaanwar90@yahoo.com', 'phone': '00966118024331'}, {'name': 'Elsadig Ezat, MBBS', 'role': 'CONTACT', 'email': 'Eezat@sfh.med.sa', 'phone': '00966535755004'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2 months', 'ipdSharing': 'YES', 'description': 'It will be provided on request', 'accessCriteria': 'On request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Security Forces Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anesthesia', 'investigatorFullName': 'Anwar ul Huda', 'investigatorAffiliation': 'Security Forces Hospital'}}}}