Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-08 @ 4:21 PM
Study NCT ID:
NCT07001605
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Block Vs Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of recovery', 'timeFrame': '24 hour to 25 hour after surgery', 'description': 'using the QoR-15 questionnaire'}], 'secondaryOutcomes': [{'measure': 'pain assessment', 'timeFrame': '30 minutes postoperatively till 24 hours postoperatively', 'description': 'numerical rating scale'}, {'measure': 'nalbuphine requirement', 'timeFrame': '30 minutes postoperatively till 24 hours postoperatively', 'description': 'mg'}, {'measure': 'time to rescue analgesia', 'timeFrame': '30 minutes postoperatively till 24 hours postoperatively', 'description': 'hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Decompression', 'Analgesia', 'Erector Spinae Plane Block', 'Ketamine']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the quality of recovery of the erector spinae plane block (ESPB) versus ketamine-based multimodal analgesia regimen after spine decompressive surgery.', 'detailedDescription': "Preoperatively, standard monitors will be attached (electrocardiogram, noninvasive blood pressure, and pulse oximetry) and intravenous access will be obtained. Dexamethasone will be administered at dose of 4 mg as an antiemetic prophylaxis.\n\nThirty min before induction of anesthesia all patients will receive 15 mg ketorolac and 1 gm paracetamol intravenously.\n\nGeneral anesthesia will be induced by 1 mcg/kg fentanyl and 2 mg/kg propofol titrated till loss of verbal response. Tracheal intubation will be facilitated by 0.5 mg/kg atracurium. General anesthesia will be maintained by isoflurane (end-tidal isoflurane concentration of 1-1.2%) in air-oxygen admixture.\n\nFentanyl boluses of 50 mcg will be given in case of inadequate analgesia (heart rate and or systolic blood pressure increase by 20% from the baseline in absence of other causes) Intraoperative hemodynamic management will be according to the discretion of the attending anesthetist.\n\nPostoperatively, all Patients will receive oral 1 gm of paracetamol every 6 h and 400 mg ibuprofen every 8 h.\n\nPain assessments using NRS (Numerical Rating Scale) at rest and during movement at 0.5 , 4, 10, 18 and 24 h postoperatively. If NRS score is \\> 3, intravenous nalbuphine 0.1 mg/kg (lean body weight) titrated to response will be given (maximum single dose is 20 mg and maximum daily dose is 160 mg).\n\nIntravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs.\n\nAt the end of 24 h postoperatively, patient's quality of recovery will be assessed using QoR-15 questionnaire and patient's satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) status of I-III\n* scheduled for open lumber decompression surgery for degenerative stenosis or trauma involving 1or 2 levels without fusion.\n\nExclusion Criteria:\n\n* Refusal to participate\n* Contraindication for peripheral regional anesthesia such as infection and coagulopathy.\n* Inability to comprehend the Numeric Rating Scale (NRS) or Patients who has cognitive function impairment\n* Preoperative renal or hepatic insufficiency\n* History of Opioid abuse.\n* Allergy to any of the study drugs'}, 'identificationModule': {'nctId': 'NCT07001605', 'briefTitle': 'Erector Spinae Block Vs Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Comparing the Quality of Recovery of Erector Spinae Block Versus Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'N-18-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine group', 'description': 'Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery.', 'interventionNames': ['Drug: ketamine', 'Other: Wound infiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESPB group', 'description': 'Patients will be receiving erector spinae plane block', 'interventionNames': ['Other: Erector Spinae Plane Block']}], 'interventions': [{'name': 'ketamine', 'type': 'DRUG', 'description': 'after induction of anesthesia, patients will receive ketamine bolus of 0.5 mL/kg followed by continuous infusion of 0.12 mL/k/hr until the end of surgical procedure.', 'armGroupLabels': ['ketamine group']}, {'name': 'Erector Spinae Plane Block', 'type': 'OTHER', 'description': 'after induction of anesthesia, patients will receive ultrasound guided ESPB. A total of 40 mL of 0.25% bupivacaine will be injected bilaterally at the level of transverse process opposing to the mid-point of the planned incision.', 'armGroupLabels': ['ESPB group']}, {'name': 'Wound infiltration', 'type': 'OTHER', 'description': 'wound infiltration at the end of the surgery before the closure of fascia and subcutaneous tissues using a total of 20 ml of 0.25% bupivacaine', 'armGroupLabels': ['ketamine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Anesthesia, Pain Management and Surgical ICU Department', 'role': 'CONTACT', 'email': 'Anesthesia.kasralainy@gmail.com', 'phone': '00201222224057'}], 'facility': 'Kasr Alaini Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ahmed hasanin', 'role': 'CONTACT', 'email': 'ahmedmohamedhasanin@gmail.com', 'phone': '01095076954'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data used for statistical analysis are available from the PI upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maha Mostafa Ahmad, MD', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}