Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06662318
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Pain Management for Lumbar 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': 'D005283', 'term': 'Fentanyl'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.', 'timeFrame': '2 months', 'description': 'Value of non-opioid injection in Pain Reduction post operatively manifested by recurrence of pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Perioperative pain management is crucial for patients undergoing elective lumbar spine surgery. Moderate to severe postoperative pain can significantly impact recovery, worsen patient outcomes, and potentially lead to chronic pain.\n\nOpioids have traditionally been the mainstay of postoperative pain management. However, their use is associated with several adverse effects, including nausea, vomiting, respiratory depression, and the risk of developing chronic pain. To mitigate these risks, there is a growing emphasis on multimodal analgesic approaches that combine various non-opioid medications to provide effective pain relief.\n\nNon-opioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs), regional anesthesia techniques, and adjuvant medications, can be used to reduce opioid requirements and improve patient outcomes. By carefully selecting and combining these modalities, clinicians can optimize pain management strategies for individual patients, minimizing the need for opioids and their associated side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had LDD and required lumbar discectomy,\n* Patients are free of exclusion criteria and accepted to participate in the study.\n\nExclusion Criteria:\n\n* The presence of other indications for spinal surgery;\n* Obesity of grade ≥II;\n* Patients of ASA grade \\>II;\n* opioid dependence for preoperative pain;\n* The presence of other causes of preoperative pain;\n* The presence of preoperative psychiatric manifestations especially delirium and/or cognitive dysfunction;\n* The presence of contraindications for the use of the study drugs;\n* The presence of uncontrolled cardiac, renal, or hepatic disorders and essential hypertension.'}, 'identificationModule': {'nctId': 'NCT06662318', 'briefTitle': 'Perioperative Pain Management for Lumbar Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Perioperative Analgesic Manipulations to Mitigate Pain After Elective Lumbar Spinal Surgeries: A Prospective Case-controlled Study', 'orgStudyIdInfo': {'id': 'RC 22/10/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group L', 'interventionNames': ['Drug: Lidocaine Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group F', 'interventionNames': ['Drug: Fentanyl Citrate']}], 'interventions': [{'name': 'Fentanyl Citrate', 'type': 'DRUG', 'description': 'Fentanyl was given as a bolus of 1 µg/kg injected followed by a fentanyl infusion of 0.4 µg/kg/h. Fentanyl infusion was continued as Postoperative analgesia for 24 hours in a dose of 0.3 µg/kg/h.', 'armGroupLabels': ['Group F']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine was given as a loading dose of 0.6 µg/kg, which was diluted to a total volume of 10 cc of normal saline and injected before induction of anesthesia over 10 minutes. Then, a DXM infusion prepared to provide 0.2-0.7 µg/kg/h was started Intraoperative; Postoperative DXM infusion was provided in a dose of 0.15 µg/kg/h for 24-h.', 'armGroupLabels': ['Group D']}, {'name': 'Lidocaine Hydrochloride', 'type': 'DRUG', 'description': 'Lidocaine hydrochloride was provided as 2 mg/kg slowly IV before induction of anesthesia and as an IV infusion at a rate of 3 mg/kg/h. Postoprative lidocaine infusion at a dose of 1.5 mg/kg/h was administered for 24 Postoprative hours.', 'armGroupLabels': ['Group L']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'El Qalyoubia', 'country': 'Egypt', 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer of Anesthesia, Pain & ICU', 'investigatorFullName': 'Azza Mahrous Shaffik', 'investigatorAffiliation': 'Benha University'}}}}