Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 1:14 AM
Study NCT ID:
NCT06282666
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbar ESPB in Hip Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D015360', 'term': 'Analgesia, Epidural'}, {'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}, {'id': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}, {'id': 'D064232', 'term': 'Visual Analog Scale'}, {'id': 'D000077708', 'term': 'Sitting Position'}, {'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}, {'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.\n\nPhysiotherapists assessing outcomes will not be aware of patient allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups will be randomly allocated to Epidural and ESPB (1:1)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opiod consumtion with PCA', 'timeFrame': 'From the admission to the postoperative care unit to the next postoperative day for 24 hours.', 'description': 'Oxycodone consumtion used with a patient-controlled analgesia pump'}], 'secondaryOutcomes': [{'measure': 'Pain at rest', 'timeFrame': '24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation', 'description': 'Pain measured at rest on the VAS (0-10)'}, {'measure': 'Pain upon activity', 'timeFrame': '24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation', 'description': 'Pain measured upon activity on the VAS (0-10)'}, {'measure': 'Lovett test', 'timeFrame': '24 hours before the surgery, 24 and 48 hours after the operation', 'description': "The quadriceps femori's muscle strength on the Lovett scale (0-5)"}, {'measure': 'TUG', 'timeFrame': '24 hours before the surgery, 24 and 48 hours after the operation', 'description': 'Timed Up and Go test in seconds'}, {'measure': 'QoR-40', 'timeFrame': 'It will be measured 24 hours, 30 days, and three months following the surgery.', 'description': 'quality of recovery 40'}, {'measure': 'NPSI', 'timeFrame': '24 hours before the surgery and 3 and 6 months following the operation', 'description': 'The Neuropathic Pain Symptom Inventory will be measured personally and after the discharge with a phone interview.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae plane block', 'epidural analgesia', 'quality of recovery', 'patient-controlled analgesia', 'Timed Up and Go test', 'visual analog scale', 'neuropathic pain symptom inventory', 'Lovett scale', 'spinal anesthesia'], 'conditions': ['Coxarthrosis', 'Pain, Postoperative', 'Pain, Acute', 'Pain, Chronic', 'Postoperative Pain, Chronic', 'Analgesia', 'Quality of Life', 'Anesthesia', 'Spinal']}, 'referencesModule': {'references': [{'pmid': '38084571', 'type': 'BACKGROUND', 'citation': 'Hanych A, Kutnik P, Pasiak P, Zakrzewska-Szalak A, Wichowska O, Jednakiewicz M, Nogalski A, Piwowarczyk P, Borys M. Continuous lumbar erector spinae plane block as an alternative to epidural analgesia in pain treatment in patients undergoing hip replacement surgery - a prospective pilot study. Anaesthesiol Intensive Ther. 2023;55(4):272-276. doi: 10.5114/ait.2023.132517.'}]}, 'descriptionModule': {'briefSummary': 'In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed.', 'detailedDescription': "This is a prospective trial in patients undergoing elective hip replacement surgery.\n\nWritten informed consent will be obtained from each patient, and our study will be conducted following the tenets of the Declaration of Helsinki for medical research involving human subjects.\n\nBefore the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed.\n\nEach participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (Epidural) group and the continuous lumbar erector spinae plane block (ESPB) group. Both regional techniques will be continued during the first day. Investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (PCA) pump. At several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (VAS, 0-10), their quadriceps femoris muscle strength on the Lovett scale (0-5), and their ability to sit, stand upright, and walk on the Timed Up and Go test. Moreover, the patient's recovery will be assessed through the Quality of Recovery 40 (QoR-40) questionnaire on the first postoperative day.\n\nAfter the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary hip replacement surgery due to coxarthrosis\n* anesthetized with spinal technique\n* able to use PCA pump\n* having access to phone\n\nExclusion Criteria:\n\n* patients taking painkillers not related to coxarthrosis;\n* having active cancer,\n* dementia or challenging contact with the patient;\n* suffering from depression or other psychiatric disorders that required antidepressant treatment;\n* consuming alcohol or recreational drug addiction;\n* contraindications to the regional block.'}, 'identificationModule': {'nctId': 'NCT06282666', 'acronym': 'ESPB_HIP', 'briefTitle': 'Lumbar ESPB in Hip Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing Hip Replacement Surgery', 'orgStudyIdInfo': {'id': 'KE-0254/150/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epidural', 'description': "Combined spinal and epidural anesthesia will be performed before the surgery in the patient's lateral position with the operated hip down. The Espocan set will be used (B.Braun). After identification of the epidural space on the level of L3/L4, 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be injected through the 27 G pencil point spinal needle. Then, the epidural catheter will be placed and a test dose of 2% lidocaine (2 mL) will be administered. At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL). Moreover, we will administer 5 mg of oxycodone i.v.\n\nthe mixture of bupivacaine and fentanyl will be administered in a constant flow of 5 mL/h for a day.", 'interventionNames': ['Procedure: Spinal anesthesia', 'Procedure: Epidural analgesia', 'Procedure: patient-controlled analgesia', 'Diagnostic Test: Timed Up and Go test', 'Diagnostic Test: neuropathic pain symptom inventory', 'Diagnostic Test: Lovett test', 'Diagnostic Test: Visual analog scale', 'Diagnostic Test: Quality of Recovery 40', 'Diagnostic Test: Ability to sit, stand upright, and walk']}, {'type': 'EXPERIMENTAL', 'label': 'ESPB', 'description': "Spinal anesthesia will be performed in the patient's lateral position with the operated hip down. 0.5% bupivacaine (Marcaine Heavy Spinal) with fentanyl (5 mcg/mL) will be used and a 25-27 G pencil point spinal needle.\n\nThe lumbar ESPB will be performed under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, a catheter will be left in the ESP. Then, we will administer 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL. Moreover, 5 mg of oxycodone i.v. will be administered A mixture of 0.1% bupivacaine with fentanyl (2 mcg/mL) will be given in a constant flow of 5 mL/h for a day.", 'interventionNames': ['Procedure: Spinal anesthesia', 'Procedure: lumbar erector spinae plane block', 'Procedure: patient-controlled analgesia', 'Diagnostic Test: Timed Up and Go test', 'Diagnostic Test: neuropathic pain symptom inventory', 'Diagnostic Test: Lovett test', 'Diagnostic Test: Visual analog scale', 'Diagnostic Test: Quality of Recovery 40', 'Diagnostic Test: Ability to sit, stand upright, and walk']}], 'interventions': [{'name': 'Spinal anesthesia', 'type': 'PROCEDURE', 'otherNames': ['Subarachnoid anesthesia'], 'description': 'Before the beginning of surgery, all patients will be anesthetized with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 1.5 - 2.5 mL solution. A pencil point spinal needle will be used.', 'armGroupLabels': ['ESPB', 'Epidural']}, {'name': 'lumbar erector spinae plane block', 'type': 'PROCEDURE', 'otherNames': ['ESPB'], 'description': 'Investigators will perform the lumbar ESPB under ultrasound control at the L3 level on the ipsilateral site of the surgery. After dissection with 0.9 NaCl, we will leave a catheter in the ESP. Then, we used 0.25% bupivacaine with epinephrine (5mcg/mL), 0.4 mL per kg, up to 40 mL.', 'armGroupLabels': ['ESPB']}, {'name': 'Epidural analgesia', 'type': 'PROCEDURE', 'description': 'After identifying the epidural space and spinal anesthesia (combined technique), a catheter will be placed in the epidural space. Investigators will give an epidural catheter a test dose of 2% lidocaine (2 mL). At the end of the surgery, the patient will receive 5 mL of a mixture containing 0.1% bupivacaine with fentanyl (2 mcg/mL).', 'armGroupLabels': ['Epidural']}, {'name': 'patient-controlled analgesia', 'type': 'PROCEDURE', 'otherNames': ['PCA'], 'description': 'Each participant will receive a pump with oxycodone (1mg/ml) using a patient-controlled analgesia (PCA) technique, a bolus of 1 mL, and a lockout of 5 minutes for the first postoperative day.', 'armGroupLabels': ['ESPB', 'Epidural']}, {'name': 'Timed Up and Go test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['TUG'], 'description': 'Investigators will measure the time the patient took to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while rotating 180 degrees. We will assess the patient before the surgery and 24 and 48 hours after hip replacement.', 'armGroupLabels': ['ESPB', 'Epidural']}, {'name': 'neuropathic pain symptom inventory', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['NPSI'], 'description': 'The Neuropathic Pain Symptom Inventory (0-100; 0 denotes no pain, 100 the most severe pain) will be evaluated before the surgery and three and six months following the procedure.', 'armGroupLabels': ['ESPB', 'Epidural']}, {'name': 'Lovett test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A physiotherapist will use the six-grade Lovett scale to measure muscle strength, in which 0 denotes no muscle contractility, and 5 denotes the complete range of motion against gravity, with full resistance. We will test this before the surgery, 24 and 48 hours after the operation.', 'armGroupLabels': ['ESPB', 'Epidural']}, {'name': 'Visual analog scale', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['VAS'], 'description': 'Investigators will measure pain intensity with VAS (0-10; 0 denotes no pain, 10 maximal pain) before and after the surgery. Pain will be evaluated at rest and upon the activity.', 'armGroupLabels': ['ESPB', 'Epidural']}, {'name': 'Quality of Recovery 40', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['QoR-40'], 'description': 'Investigators will assess the quality of recovery with QoR-40 a day after the surgery, a month, and three months following the procedure. The minimal score is 40, and the maximal is 200. The higher the result, the better the quality of recovery is.', 'armGroupLabels': ['ESPB', 'Epidural']}, {'name': 'Ability to sit, stand upright, and walk', 'type': 'DIAGNOSTIC_TEST', 'description': "A physiotherapist will evaluate the patient's ability to sit, stand upright, and walk at planned times.", 'armGroupLabels': ['ESPB', 'Epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-081', 'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Michał A Borys, M.D. Ph.D', 'role': 'CONTACT', 'email': 'michalborys1@gmail.com', 'phone': '506350569', 'phoneExt': '+48'}, {'name': 'Paweł Kutnik, M.D.', 'role': 'CONTACT', 'email': 'pe.kutnik@gmail.com', 'phone': '608769410', 'phoneExt': '+48'}], 'facility': 'II Department of Anesthesia and Intensive Care', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}], 'centralContacts': [{'name': 'Michał Borys, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'michalborys1@gmail.com', 'phone': '506350569', 'phoneExt': '+48'}, {'name': 'Paweł Kutnik, M.D.', 'role': 'CONTACT', 'email': 'pe.kutnik@gmail.com', 'phone': '608769410', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Paweł Piwowarczyk, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Lublin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Michał Borys', 'investigatorAffiliation': 'Medical University of Lublin'}}}}