Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 4:55 PM
Study NCT ID:
NCT06721832
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2024-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS', 'timeFrame': 'VAS scores at rest and on passive neck movement postoperatively at 0, 2, 4, 6, 8, 12, 24 and 48 hours', 'description': 'Visual analogue pain score which scales from zero (no pain) to ten (unbearable pain).'}, {'measure': 'Diaphragmatic excursion', 'timeFrame': '2- Diaphragmatic excursion assessed by ultrasound will be measured at baseline, in PACU 30 minutes after recovery, and 24h postoperative', 'description': 'Diaphragmatic excursion is the movement of the thoracic diaphragm during breathing. Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. It is performed by asking the patient to exhale and hold it.'}], 'secondaryOutcomes': [{'measure': 'morphine intake', 'timeFrame': 'During 24 hrs postoperatively', 'description': 'Amount of morphine intake, and time of first rescue analgesic request.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESP', 'PAIN', 'Posterior cervical surgery'], 'conditions': ['Cervical Spine Surgery', 'Pain Management']}, 'descriptionModule': {'briefSummary': 'Posterior cervical spine surgery, often performed on older individuals with significant comorbidities, is one of the most painful surgical operations. Anesthesiologists face a unique challenge in managing pain following these surgeries,Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016.Cervical erector spinae plane (ESP) block has been described to anesthetize the brachial plexus (BP), however, the mechanism of its clinical effect remains unknown. As the prevertebral fascia encloses the phrenic nerves, BP and erector spinae muscles to form a prevertebral compartment, a local anesthetic injected in the cervical ESP could potentially spread throughout the prevertebral compartment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* (ASA )classes I and II\n* patients of either sex\n* above the age of 18 who will undergo posterior cervical surgery\n\nExclusion Criteria:\n\n* patient's refusal to participate\n* any contraindications to peripheral nerve blocks\n* history of ischemic heart disease\n* patients on opioids for chronic pain\n* patients with significant cognitive impairment"}, 'identificationModule': {'nctId': 'NCT06721832', 'briefTitle': 'The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RC 13-10-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group E', 'description': 'patients will receive bilateral in-plane ultrasound guided erector spinea plane block with 30 ml of bupivacaine 0. 25% (15 ml in each side) after induction of general anesthesia', 'interventionNames': ['Procedure: Erector spina plane block (ESP)', 'Drug: Bupivacain (preoperative)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'description': 'patients will receive a sham block with saline at the corresponding puncture site and same volumes as in group E (sham block) after induction of general anesthesia', 'interventionNames': ['Procedure: Erector spina plane block (ESP)']}], 'interventions': [{'name': 'Erector spina plane block (ESP)', 'type': 'PROCEDURE', 'description': 'The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy\'s needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine with 150 μg of clonidine and 8 mg dexamethasone was administered deep to erector spinae muscle (ESM) bilaterally.', 'armGroupLabels': ['Group C', 'Group E']}, {'name': 'Bupivacain (preoperative)', 'type': 'DRUG', 'description': 'The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy\'s needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine with 150 μg of clonidine and 8 mg dexamethasone was administered deep to erector spinae muscle (ESM) bilaterally.', 'armGroupLabels': ['Group E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'ELkalyobia', 'country': 'Egypt', 'facility': 'Benha university', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'LECTURER', 'investigatorFullName': 'Fatma Ahmed Abdel Fatah', 'investigatorAffiliation': 'Benha University'}}}}