Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-01 @ 2:37 AM
Study NCT ID:
NCT06003933
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2023-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inter-semispinal Plane Block and Cervical Spine Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomly allocated into either of the two groups using computer generated sequence and concealed in sealed opaque envelopes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': '1 hour preoperatively', 'description': 'in years'}, {'measure': 'body mass index', 'timeFrame': '1 hour preoperatively', 'description': 'kg/m2'}], 'primaryOutcomes': [{'measure': 'postoperative rescue pethidine consumption', 'timeFrame': '48 hours after operation', 'description': 'in milligram'}], 'secondaryOutcomes': [{'measure': 'Postoperative visual analog pain score (VAS score)', 'timeFrame': '4 hours postoperatively', 'description': '0 to 10 scale as 0: no pain and 10:worst degree of pain'}, {'measure': 'Postoperative visual analog pain score (VAS score)', 'timeFrame': '8 hours postoperatively', 'description': '0 to 10 scale as 0: no pain and 10:worst degree of pain'}, {'measure': 'Postoperative visual analog pain score (VAS score)', 'timeFrame': '12 hours postoperatively', 'description': '0 to 10 scale as 0: no pain and 10:worst degree of pain'}, {'measure': 'Postoperative visual analog pain score (VAS score)', 'timeFrame': '24 hours postoperatively', 'description': '0 to 10 scale as 0: no pain and 10:worst degree of pain'}, {'measure': 'Postoperative visual analog pain score (VAS score)', 'timeFrame': '48 hours postoperatively', 'description': '0 to 10 scale as 0: no pain and 10:worst degree of pain'}, {'measure': 'time to first rescue analgesic request', 'timeFrame': '1 minute after requiring analgesics', 'description': 'in milligram'}, {'measure': 'Intraoperative fentanyl consumption', 'timeFrame': '1 minute after surgery.', 'description': 'in microgram'}, {'measure': 'Occurrence of postoperative nausea', 'timeFrame': '2 hours after operation', 'description': 'yes or no'}, {'measure': 'Occurrence of postoperative vomiting', 'timeFrame': '2 hours after operation', 'description': 'yes or no'}, {'measure': 'Occurrence of postoperative pruritis', 'timeFrame': '2 hours after operation', 'description': 'yes or no'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inter-semispinal plane block', 'Cervical spine surgery', 'Postoperative analgesia'], 'conditions': ['Post Operative Pain', 'Cervical Spine Instability']}, 'referencesModule': {'references': [{'pmid': '28291143', 'type': 'BACKGROUND', 'citation': 'Kurd MF, Kreitz T, Schroeder G, Vaccaro AR. The Role of Multimodal Analgesia in Spine Surgery. J Am Acad Orthop Surg. 2017 Apr;25(4):260-268. doi: 10.5435/JAAOS-D-16-00049.'}, {'pmid': '30853517', 'type': 'BACKGROUND', 'citation': 'Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.'}, {'pmid': '18790686', 'type': 'BACKGROUND', 'citation': 'Lumawig JM, Yamazaki A, Watanabe K. Dose-dependent inhibition of diclofenac sodium on posterior lumbar interbody fusion rates. Spine J. 2009 May;9(5):343-9. doi: 10.1016/j.spinee.2008.06.455. Epub 2008 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'The inter-semispinal plane (ISP) block is a novel ultrasound-guided technique that involves local anesthetic injection into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles with subsequent block of the dorsal rami of the cervical spinal nerves and hence can get adequate postoperative analgesia.\n\nThe authors hypothesized that ISP block can reduce the postoperative analgesic consumption in patients undergoing posterior cervical spine surgeries.\n\nThe aim of this study is to evaluate the analgesic efficacy of ISP block in patients undergoing posterior cervical spine surgery.', 'detailedDescription': 'This study will be performed in the in the Fayoum University hospital after the local Institutional Ethics Committee and local institutional review board approval. The study design will be double-blind randomized controlled study . A detailed informed consent will be signed by the eligible patients before recruitment and randomization.\n\nPatients were randomly allocated into two groups using computer generated sequence and concealed in sealed opaque envelopes.\n\nControl group (C): patients received general anesthesia only. Inter-semispinal plane (ISP) block group: patients received bilateral ultrasound guided ISP block at the level of C5.\n\nAll patients will be assessed Preoperative VAS score then premedicated orally with midazolam 0.5 mg/kg 30 min prior to surgery. All patients were monitored by 5 lead ECG, pulse oximetry, non-invasive blood pressure and capnography and an intravenous (IV) access will be established.\n\nThe technique of general anesthesia will be standardized for all patients. General anesthesia will be induced by intravenous (IV) 2 mg/kg propofol and 1 μg/kg fentanyl induction. After IV atracurium 0.5 mg/kg, orotracheal intubation was performed. Anesthesia will be maintained with isoflurane (1.2%-1.5%) in oxygen-air mixture (50%-50%). Muscle relaxation will be maintained during the procedure with atracurium in increments.\n\nAfter induction of general anesthesia, ISP blocks will be performed in the allocated group with the patient in the prone position. In both groups, the treating anesthesiologist left the operating room while another anesthesiologist experienced in ultrasound guided nerve block techniques; with no subsequent role in the study; either performed the ISP blocks in the ISP group, or just prepared the skin and scanned the site of the block using the ultrasound probe in the control group. Fifteen minutes will be awaited in all patients before the surgical procedure was allowed to start.\n\nfentanyl 0.5 μg/kg IV will be administered in case of inadequate analgesia as indicated by \\>20% increase in heart rate or mean arterial blood pressure. Total intraoperative fentanyl consumption will be recorded.\n\nAll anesthetics will be discontinued at the end of the surgical procedure. Extubation will be performed when spontaneous breathing was adequate and following prompt reversal using 0.05 mg/kg of neostigmine and 0.02 mg/kg of atropine. At the end of surgery, paracetamol 1 g will be administered IV to be repeated every 6 h postoperatively. Patients will be transferred to the PACU where HR, respiratory rate, SpO2 and systolic, diastolic and mean arterial blood pressure were monitored.\n\nSample size was calculated using G\\* Power 3.1.7.9 software program. Calculation of the sample size was based on the VAS value measured at different time points. Based on the results of a study by Mostafa et al, the authors calculated the sample size to be able to detect a difference in VAS score of 10 points with an effect size of 0.8. Using the previous data, at least 23 patients in each group were required to detect a significance difference in the postoperative pethidine consumption at α value of 0.05 and study power of 90%. The authors decided to recruit 25 patients in each group to compensate for any possible withdrawals. The sample size calculation was based on a 2-sample independent t-test (2-sided)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-II undergoing elective posterior cervical spine surgery\n\nExclusion Criteria:\n\n* Patient refusal\n* Patients with any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality)\n* Known allergy to local anesthetics\n* Previous cervical disc surgery or fixation\n* Mental disorders\n* Drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT06003933', 'acronym': 'ISPB', 'briefTitle': 'Inter-semispinal Plane Block and Cervical Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University Hospital'}, 'officialTitle': 'Inter-semispinal Plane (ISP) Block for Postoperative Analgesia Following Cervical Spine Surgery: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'm644'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'patients received general anesthesia only.'}, {'type': 'EXPERIMENTAL', 'label': 'ISP group', 'description': 'patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity', 'interventionNames': ['Drug: Bupivacaine Hydrochloride', 'Drug: Lidocaine Hydrochloride', 'Device: Ultrasound', 'Device: Needle']}], 'interventions': [{'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'otherNames': ['0.25% bupivacaine HCL'], 'description': '10 ml of 0.25% bupivacaine on each side of cervical region at C5', 'armGroupLabels': ['ISP group']}, {'name': 'Lidocaine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Xylocaine'], 'description': '10ml xylocaine on each side of cervical region at C5', 'armGroupLabels': ['ISP group']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'The same anesthesiologist who is experienced in US guided regional anesthesia will perform the block.The five-layered posterior cervical muscles were identified at the level of C5 with a 6-15-MHz linear probe oriented in the transverse plane (SonoSite Edge, Bothell, Washington). The fifth cervical spine was counted from the C7 spinous process with the probe sliding cranially.', 'armGroupLabels': ['ISP group']}, {'name': 'Needle', 'type': 'DEVICE', 'description': 'the needle (22- G, 50-mm block needle (Visioplex, Vygon) was introduced in-plane through the skin and advanced into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles. After negative aspiration for blood, 20 ml of bupivacaine 0.25% was injected5.', 'armGroupLabels': ['ISP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63514', 'city': 'Al Fayyum', 'state': 'Faiyum Governorate', 'country': 'Egypt', 'facility': 'Fayoum University Hospital', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'overallOfficials': [{'name': 'Mohamed A Shawky, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fayoum University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yasser S Mostafa, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia', 'investigatorFullName': 'Yasser S Mostafa, MD', 'investigatorAffiliation': 'Fayoum University Hospital'}}}}