Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-03 @ 3:23 PM
Study NCT ID:
NCT07240961
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbal Erector Spinae Plane Block for Pain Management After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': 'Day 1', 'description': 'total morphine dose'}], 'secondaryOutcomes': [{'measure': 'pain scores', 'timeFrame': 'Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.', 'description': 'numerical pain rating scale \\[1 to 10 worse outcome\\]'}, {'measure': 'intraoperative opioid consumption', 'timeFrame': 'end of surgery', 'description': 'total fentanyl dose'}, {'measure': 'pain on sitting position', 'timeFrame': 'Day 1', 'description': 'numerical pain rating scale \\[1 to 10 worse outcome\\]'}, {'measure': 'QR 9 score', 'timeFrame': 'Day 2', 'description': 'quality of recovery score \\[0 to 18 best outcome\\]'}, {'measure': 'ROM', 'timeFrame': 'Day 1', 'description': 'Range of mouvement \\[0° to 90°best outcome\\]'}, {'measure': 'pain during walk', 'timeFrame': 'Day 7', 'description': 'numerical pain rating scale \\[1 to 10 worse outcome\\]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip arthroplasty', 'Lumbal Erector Spinae Plane Block', 'pain managment'], 'conditions': ['Total Hip Arthroplasty (THA)']}, 'descriptionModule': {'briefSummary': "The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. The ESP block is one of the inter-fascicular blocks and it's an easy-to-perform technique.In the literature, it has been reported that Lumbar ESPB provides effective analgesia after a hip surgery.\n\nThe purpose of this prospective randomized study was to compare the analgesic effects of the ultrasound-guided lumbar Erector Spinae Plane block on postoperative pain management versus the multimodal analgesia after total hip arthroplasty.", 'detailedDescription': 'Patients aged more than 18 years, ASA I-III scheduled for primary total hip arthroplasty with lateral approach and under general anesthesia Patients were randomly assigned, into 1 of 2 groups, namely, group ESPBL and group Placebo, using sealed envelopes\n\n* For ESPBL group: Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.\n* For Placebo group: patients had multimodal analgesia without lumbar ESP block Patients will be transferred to continuous care unit for 24 hours.\n\nPost-operative analgesia will include:\n\n1. Paracetamol 1g IV every 8 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks.\n2. Diclofenac sodium(50mg) 1 tablet x 2 per day for 5 days.\n3. PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, programmed as: Bolus of 1mg/ refractory period of 10 min/ maximum dose set up at 10mg every 12h.\n\nThe primary outcome of the study is to compare postoperative opioids consumption in the first 24 postoperative hours.\n\nSecondary endpoints:\n\nSecondary outcomes are: intraoperative opioid consumption, postoperative pain scores, sitting position and adverse effects related to opioids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary total hip arthroplasty with lateral approach and under general anesthesia .\n\nExclusion Criteria:\n\n* • Contraindication or refusal to regional anesthesia\n\n * Contraindication to non-steroidal anti-inflammatory (NSAID's)\n * Allergy to opioids\n * Allergy to paracetamol\n * Creatinine clearance \\< 30ml/min\n * Weight\\<50 kg or \\>100kg\n * Psychiatric disorders and difficulty of communication\n * Lower limb neurological deficit\n * Patients undergoing bilateral or revision total hip replacement"}, 'identificationModule': {'nctId': 'NCT07240961', 'briefTitle': 'Lumbal Erector Spinae Plane Block for Pain Management After Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Ultrasound-Guided Lumbal Erector Spinae Plane Block on Postoperative Pain Management After Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'IMKO-CE 115/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hip arthroplasty with nerve block', 'description': 'Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block', 'interventionNames': ['Procedure: Lumbal Erector Spinae Plane Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'hip arthroplasty with intravenous pain killers', 'description': 'intravenous pain killers', 'interventionNames': ['Procedure: intravenous pain killers']}], 'interventions': [{'name': 'Lumbal Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.', 'armGroupLabels': ['hip arthroplasty with nerve block']}, {'name': 'intravenous pain killers', 'type': 'PROCEDURE', 'description': 'intravenous pain killers', 'armGroupLabels': ['hip arthroplasty with intravenous pain killers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Manouba', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'KAABACHI OLFA OLFA, PROFESSOR', 'role': 'CONTACT', 'email': 'olfa.kaabach@gmail.com', 'phone': '0021098317381'}], 'facility': 'Kassab Orthopedic Institute', 'geoPoint': {'lat': 36.81006, 'lon': 10.09557}}], 'centralContacts': [{'name': 'KAABACHI OLFA', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Olfa kaabachi, MD', 'investigatorAffiliation': 'University Tunis El Manar'}}}}